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The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Astron Stent Group | Experimental | Participants indicated for stenting in iliac atherosclerotic lesions. Intervention: Device: Astron Stents |
|
| Pulsar Stent Group | Experimental | Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions. Intervention: Device: Pulsar Stents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astron Stents | Device | Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Endpoint for the Pulsar Stent: Primary Patency | The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis. | 12 months |
| Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events | The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation. | 30 days |
| Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE) | The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%. | 12 months |
| Percentage of Participants With Primary Safety Endpoint (Post Market Analysis) | Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months. | 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation | Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent. | 30 days |
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Inclusion Criteria
To support the objectives of this study, the following initial inclusion criteria must be met for a subject to be enrolled and considered for the index procedure:
For a subject to receive an investigational stent, the following procedure-related criteria must be met:
Exclusion Criteria
To support the objectives of this study, the following initial exclusion criteria must not be present for a subject to be enrolled:
For a subject to receive an investigational stent the following procedure-related criteria must not be present:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Burket, MD | University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fremont | California | 94538 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27542591 | Background | Burket MW, Brodmann M, Metzger C, Tan K, Jaff MR. Twelve-Month Results of the Nitinol Astron Stent in Iliac Artery Lesions. J Vasc Interv Radiol. 2016 Nov;27(11):1650-1656.e1. doi: 10.1016/j.jvir.2016.06.008. Epub 2016 Aug 16. |
| Label | URL |
|---|---|
| Twelve-Month Results of the Nitinol Astron Stent in Iliac Artery Lesions | View source |
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There is no plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Astron Stent Group | Subjects implanted with an Astron stent. |
| FG001 | Pulsar Stent Group | Subjects implanted with an Astron Pulsar or Pulsar-18 stent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Pulsar Stents | Device | Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries. |
|
|
| Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate |
Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate. |
| 12 months |
| Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V. | 12 months |
| Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate | Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent. | 12 months |
| Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate | Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis. | 12 months |
| Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency | Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization [TVR]) for the Astron and Pulsar stent at 12 months post-index procedure. | 12 months |
| Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency | Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure. | 12 months |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm. | 12 months |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure. | 12 months |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 | 12 months |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 | 12 months |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 | 12 months |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 | 12 months |
| Acute Procedural Success for Astron and Pulsar Stent | Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge. | 30 days |
| Clinical Success | Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure. | 30 days |
| Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates | Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details. | 12 month |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate | Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | 30 days |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months | Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | 12 months |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months | Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | 12 months |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months | Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | 12 months |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success | Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | Acute / Date of Procedure |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success | Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | 30 days |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate | Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | 12 months |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months | Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | 12 months |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months | Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | 12 months |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months | Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | 12 months |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months | Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | 12 months |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success | Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | Acute / Date of Procedure |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success | Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | 30 days |
| Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval) | Evaluate the rate of freedom from target lesion revascularization (TLR) and/or index limb amputation for the Pulsar stent. | 24 Months |
| Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval) | Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent. | 24 Months |
| Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval). | Evaluate the MAE rate and the individual component rates of mortality at 30 days post-index procedure, target lesion revascularization (TLR) and index limb amputation for the Pulsar stent. | 36 Months |
| Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group) | 24 Months |
| Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group) | 36 Months |
| Number of Participants With Stent Fracture at 24 Months (Post Approval). | 24 Months |
| Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group). | 36 Months |
| Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group). | Summary of serious adverse event rates at 36 months. Refer to SAE section. | 36 months |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Rockford | Illinois | 61107 | United States |
| Munster | Indiana | 46321 | United States |
| Houma | Louisiana | 70360 | United States |
| Lansing | Michigan | 48912 | United States |
| Saginaw | Michigan | 48601 | United States |
| Wyoming | Michigan | 49519 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| Tupelo | Mississippi | 38801 | United States |
| Kansas City | Missouri | 64114 | United States |
| Ridgewood | New Jersey | 07450 | United States |
| New York | New York | 10065 | United States |
| The Bronx | New York | 10467 | United States |
| Gastonia | North Carolina | 28054 | United States |
| High Point | North Carolina | 27262 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Toledo | Ohio | 43606 | United States |
| Toledo | Ohio | 43614 | United States |
| Camp Hill | Pennsylvania | 17011 | United States |
| Doylestown | Pennsylvania | 18901 | United States |
| Langhorne | Pennsylvania | 19047 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| Providence | Rhode Island | 02906 | United States |
| Greenville | South Carolina | 29605 | United States |
| Rock Hill | South Carolina | 29732 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Amarillo | Texas | 79106 | United States |
| Austin | Texas | 78745 | United States |
| McKinney | Texas | 75069 | United States |
| Tyler | Texas | 75701 | United States |
| Waco | Texas | 76712 | United States |
| Montreal | Canada |
| Toronto | Canada |
| COMPLETED |
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| NOT COMPLETED |
|
The two arms of the BIOFLEX-I study were distinct with no overlap. Totals present here were automatically generated by the clinicaltrials.gov system. Four participants were enrolled in both the Astron and Pulsar stent groups, as allowed in the study protocol. Therefore any presented totals may not be accurate aggregates of data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Astron Stent Group | Subjects implanted with an Astron stent. |
| BG001 | Pulsar Stent Group | Subjects implanted with an Astron Pulsar or Pulsar-18 stent. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
| ||||||||||||||||
| Medical History | Number | Participants |
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| Lesion Location | Number | Participants |
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| Lesion Calcification | Number | Participants |
| ||||||||||||||||
| Lesion Length | Mean | Standard Deviation | mm |
| |||||||||||||||
| Vessel Diameter | Mean | Standard Deviation | mm |
| |||||||||||||||
| Distal Vessel Runoff | Number | Participants |
| ||||||||||||||||
| Trans-Atlantic Inter-Society Consensus (TASC II) Type | TASC II grading is from the Trans-Atlantic Inter-Society Consensus. Type A lesions include a single stenosis <10 cm long or a single occlusion <5cm long; type B lesions include multiple lesions <5 cm, a single lesion <15cm, or a single popliteal stenosis; type C lesions include multiple stenosis or occlusions >15 cm with or without calcification, or a chronic total occlusion >20cm involving the popliteal; type D lesions include chronic total occlusions of the popliteal artery and proximal vessels. Generally, Type D lesions are mores severe than Type A lesions. | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness Endpoint for the Pulsar Stent: Primary Patency | The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis. | Participants for whom patency could be confirmed at 12 months. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
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| Primary | Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events | The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation. | All participants implanted with an Astron Pulsar or Pulsar-18 stent. | Posted | Number | 95% Confidence Interval | Percentage of participants | 30 days |
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| Primary | Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE) | The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%. | Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
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| Primary | Percentage of Participants With Primary Safety Endpoint (Post Market Analysis) | Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months. | Posted | Number | 95% Confidence Interval | percentage of participants | 36 Months |
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| Secondary | Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation | Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent. | All participants implanted with an Astron Pulsar or Pulsar-18 stent. | Posted | Number | 95% Confidence Interval | Percentage of participants | 30 days |
|
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| Secondary | Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate | Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate. | Participants who reached at least 395 calendar days post procedure. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
|
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| Secondary | Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V. | Participants with 12 month (395 day) diagnostic X-ray available for fracture evaluation. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate | Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent. | Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate | Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis. | Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
|
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| Secondary | Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency | Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization [TVR]) for the Astron and Pulsar stent at 12 months post-index procedure. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
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| Secondary | Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency | Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
|
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| Secondary | Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm. | Analysis conducted on paired data. ABI measurements were available for 141 participants from both baseline and the 12-month visit for the Astron stent group. ABI measurements were available for 266 participants from both baseline and the 12-month visit for the Pulsar stent group. | Posted | Mean | Standard Deviation | Ratio (ABI score) | 12 months |
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| Secondary | Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure. | Analysis conducted on paired data. Six-minute walk test results were available for 131 participants from both baseline and the 12-month visit for the Astron stent group. Six-minute walk test results were available for 247 participants from both baseline and the 12-month visit for the Pulsar stent group. | Posted | Mean | Standard Deviation | Feet | 12 months |
|
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| Secondary | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 | Analysis conducted on paired data. WIQ PAD responses were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ PAD responses were available for 265 participants from both baseline and the 12-month visit for the Pulsar stent group. | Posted | Mean | Standard Deviation | Units on a scale (WIQ score) | 12 months |
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| Secondary | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 | Analysis conducted on paired data. WIQ walking distance scores were available for 144 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking distance scores were available for 264 participants from both baseline and the 12-month visit for the Pulsar stent group. | Posted | Mean | Standard Deviation | Units on a scale (WIQ score) | 12 months |
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| Secondary | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 | Analysis conducted on paired data. WIQ walking speed scores were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking speed scores were available for 263 participants from both baseline and the 12-month visit for the Pulsar stent group. | Posted | Mean | Standard Deviation | Units on a scale (WIQ score) | 12 months |
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| Secondary | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 | Analysis conducted on paired data. WIQ stair climbing scores were available for 142 participants from both baseline and the 12-month visit for the Astron stent group. WIQ stair climbing scores were available for 255 participants from both baseline and the 12-month visit for the Pulsar stent group. | Posted | Mean | Standard Deviation | Units on a scale (WIQ score) | 12 months |
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| Secondary | Acute Procedural Success for Astron and Pulsar Stent | Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge. | Includes all participants who underwent implantation. | Posted | Number | 95% Confidence Interval | Percentage of participants | 30 days |
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| Secondary | Clinical Success | Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure. | The Astron stent group includes all participants who underwent implantation. The Pulsar stent group includes all participants who underwent implantation except for one, due to subject death occurring in the first 30 days. | Posted | Number | 95% Confidence Interval | Percentage of participants | 30 days |
|
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| Secondary | Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates | Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details. | Includes all participants who underwent implantation. | Posted | Number | Participants with event | 12 month |
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| Secondary | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate | Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 30 days |
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| Secondary | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months | Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment. | Posted | Number | Percentage of participants | 12 months |
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| Secondary | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months | Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 12 months |
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| Secondary | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months | Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 12 months |
| ||||||||||||||||||||||||||||
| Secondary | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success | Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | Includes all participants who underwent implantation. | Posted | Number | Percentage of participants | Acute / Date of Procedure |
| ||||||||||||||||||||||||||||
| Secondary | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success | Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. | Includes all participants who underwent implantation. | Posted | Number | Percentage of participants | 30 days |
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| Secondary | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate | Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 12 months |
|
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| Secondary | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months | Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 12 months |
|
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| Secondary | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months | Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 12 months |
|
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| Secondary | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months | Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months | Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success | Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | Acute / Date of Procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success | Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. | Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population. | Posted | Number | Percentage of participants | 30 days |
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| Secondary | Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval) | Evaluate the rate of freedom from target lesion revascularization (TLR) and/or index limb amputation for the Pulsar stent. | Evaluable participants for TLR at 24 months. | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval) | Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent. | Evaluable participants at 24 months. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 Months |
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| Secondary | Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval). | Evaluate the MAE rate and the individual component rates of mortality at 30 days post-index procedure, target lesion revascularization (TLR) and index limb amputation for the Pulsar stent. | Evaluable participants at 36 months. | Posted | Number | 95% Confidence Interval | percentage of participants | 36 Months |
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| Secondary | Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group) | Evaluable participants for TLR at 24 months. | Posted | Number | 95% Confidence Interval | percentage of Participants | 24 Months |
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| Secondary | Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group) | Evaluable participants for TLR at 36 months. Pulsar Stent Group Post Market Analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 36 Months |
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| Secondary | Number of Participants With Stent Fracture at 24 Months (Post Approval). | Evaluable participants for stent fracture at 24 months. Pulsar Stent Group Post Market Analysis. | Posted | Count of Participants | Participants | 24 Months |
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| Secondary | Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group). | Evaluable participants for stent fracture at 36 months. Pulsar Stent Group Post Market Analysis. | Posted | Count of Participants | Participants | 36 Months |
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| Secondary | Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group). | Summary of serious adverse event rates at 36 months. Refer to SAE section. | Pulsar Stent Group Post Market Analysis. | Posted | Count of Participants | Participants | 36 months |
|
|
Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events.
For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Astron Stent Group | Subjects indicated for stenting in iliac atherosclerotic lesions. | 5 | 161 | 67 | 161 | 33 | 161 |
| EG001 | Pulsar Stent Group | Subjects indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions. | 27 | 302 | 180 | 302 | 179 | 302 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal coagulation profile | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding requiring treatment | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Epistaxis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Abdominal aortic aneurysm | Cardiac disorders | Systematic Assessment |
| ||
| Angina | Cardiac disorders | Systematic Assessment |
| ||
| Atrial arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac catheterization | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Dilated cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Dizziness | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea | Cardiac disorders | Systematic Assessment |
| ||
| Edema | Cardiac disorders | Systematic Assessment |
| ||
| Elevated troponin | Cardiac disorders | Systematic Assessment |
| ||
| Fatigue | Cardiac disorders | Systematic Assessment |
| ||
| Fluctuating blood pressure | Cardiac disorders | Systematic Assessment |
| ||
| Heart block | Cardiac disorders | Systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Hypertensive crisis | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Ischemic cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Medication reaction/toxicity | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Patent foramen ovale closure | Cardiac disorders | Systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Superior mesenteric artery stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Valvular heart disease | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Worsening cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Worsening coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Worsening heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Endocrine disorders | Systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
| ||
| Hyperlipidemia | Endocrine disorders | Systematic Assessment |
| ||
| Hypoglycemia | Endocrine disorders | Systematic Assessment |
| ||
| Worsening diabetic control | Endocrine disorders | Systematic Assessment |
| ||
| Bleeding left eye | Eye disorders | Systematic Assessment |
| ||
| Cataract | Eye disorders | Systematic Assessment |
| ||
| Horner's syndrome, right eye | Eye disorders | Systematic Assessment |
| ||
| Neovascular glaucoma | Eye disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bariatric surgery | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colon/rectal polyp(s) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colonoscopy | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gallstone | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric bypass surgery | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric ulcer(s) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hernia, hiatal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hernia, inguinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ischemic colitis/colon polyps | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea and/or vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Suspected abdominal ischemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ventral and umbilical hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death-cause undetermined | General disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Open or non-healing wound/ulcer | General disorders | Systematic Assessment |
| ||
| Open wounds due to injury | General disorders | Systematic Assessment |
| ||
| Syncope | General disorders | Systematic Assessment |
| ||
| Traumatic injury | General disorders | Systematic Assessment |
| ||
| Weakness | General disorders | Systematic Assessment |
| ||
| Bacterial infection | Infections and infestations | Systematic Assessment |
| ||
| Breast | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile | Infections and infestations | Systematic Assessment |
| ||
| E. coli infection | Infections and infestations | Systematic Assessment |
| ||
| Erysipelas | Infections and infestations | Systematic Assessment |
| ||
| Fungemia | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Groin wound | Infections and infestations | Systematic Assessment |
| ||
| Infection resulting in amputation | Infections and infestations | Systematic Assessment |
| ||
| Ingrown toenail | Infections and infestations | Systematic Assessment |
| ||
| Inner ear infection | Infections and infestations | Systematic Assessment |
| ||
| MRSA | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis resulting in amputation | Infections and infestations | Systematic Assessment |
| ||
| Perirectal abscess | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pocket infection | Infections and infestations | Systematic Assessment |
| ||
| Positive E. faecalis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Septic shock resulting in amputation | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Surgical site - elbow | Infections and infestations | Systematic Assessment |
| ||
| Thrush | Infections and infestations | Systematic Assessment |
| ||
| Toenail fungus | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Tuberculosis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urosepsis | Infections and infestations | Systematic Assessment |
| ||
| Wound drainage/Purulant drainage | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Allergic reaction to contrast media or anti-thrombotic meds | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Anaphylactic shock | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Chronic shoulder dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gonathrosis of the knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Herniated disc | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lumbar laminectomy and fusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteonecrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Vocal cord polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Axonal sensible polyneuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Carpal tunnel syndrome | Nervous system disorders | Systematic Assessment |
| ||
| Myoclonus | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Tinnitus | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Vasovagal episode | Nervous system disorders | Systematic Assessment |
| ||
| Vertigo | Nervous system disorders | Systematic Assessment |
| ||
| Altered mental status | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute pyelonephritis | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Cystocele | Renal and urinary disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Increased serum creatinine | Renal and urinary disorders | Systematic Assessment |
| ||
| Kidney stone(s) | Renal and urinary disorders | Systematic Assessment |
| ||
| Muliple organ failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Ureter obstruction | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Worsening renal function | Renal and urinary disorders | Systematic Assessment |
| ||
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Hernia vaginal | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusions | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Profound hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory compromise | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sudden respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin condition/rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Angioplasty on left external iliac and SFA | Surgical and medical procedures | Systematic Assessment |
| ||
| Failure to deliver stent to intended site | Surgical and medical procedures | Systematic Assessment |
| ||
| Hematoma | Surgical and medical procedures | Systematic Assessment |
| ||
| ICD/pacemaker device replacement | Surgical and medical procedures | Systematic Assessment |
| ||
| Nausea and/or vomiting | Surgical and medical procedures | Systematic Assessment |
| ||
| Planned carotid stenting | Surgical and medical procedures | Systematic Assessment |
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| Planned PVI in contralateral extremity | Surgical and medical procedures | Systematic Assessment |
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| Post-surgical wound discomfort | Surgical and medical procedures | Systematic Assessment |
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| Pseudoaneurysm - procedure related | Surgical and medical procedures | Systematic Assessment |
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| Thrombosis or occlusion during stenting procedure | Surgical and medical procedures | Systematic Assessment |
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| Vessel dissection or perforation during placement of thrombolysis catheter | Surgical and medical procedures | Systematic Assessment |
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| Vessel dissection or perforation during PTA/ prior to stenting | Surgical and medical procedures | Systematic Assessment |
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| Vessel dissection or perforation during stenting procedure | Surgical and medical procedures | Systematic Assessment |
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| Acute mesenteric ischemia | Vascular disorders | Systematic Assessment |
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| Arterial embolization distal to puncture site | Vascular disorders | Systematic Assessment |
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| Basilar artery stenosis | Vascular disorders | Systematic Assessment |
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| Carotid artery disease | Vascular disorders | Systematic Assessment |
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| Carotid stenosis | Vascular disorders | Systematic Assessment |
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| Compartment syndrome | Vascular disorders | Systematic Assessment |
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| Contralateral iliac dissection | Vascular disorders | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Discoloration of 5th right toe | Vascular disorders | Systematic Assessment |
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| Gangrene resulting in amputation | Vascular disorders | Systematic Assessment |
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| Hematoma - non-index procedure related | Vascular disorders | Systematic Assessment |
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| Numbness and/or tingling in lower extremities | Vascular disorders | Systematic Assessment |
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| Occlusion of bypass graft left illiopopliteal bypass conduit | Vascular disorders | Systematic Assessment |
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| Open or non-healing wound/ulcer | Vascular disorders | Systematic Assessment |
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| Peripheral ischemia | Vascular disorders | Systematic Assessment |
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| Phlegmon of the forefoot - led to amputation | Vascular disorders | Systematic Assessment |
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| Pseudoaneurysm | Vascular disorders | Systematic Assessment |
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| Pseudoaneurysm - non-index procedure related | Vascular disorders | Systematic Assessment |
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| Renal artery stenosis | Vascular disorders | Systematic Assessment |
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| Right femoral occlusion | Vascular disorders | Systematic Assessment |
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| Stenosis or occlusion in contralateral extremity | Vascular disorders | Systematic Assessment |
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| Stenosis or occlusion in target extremity outside of stent segment | Vascular disorders | Systematic Assessment |
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| Stenosis or occlusion of target lesion within stent segment | Vascular disorders | Systematic Assessment |
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| Subclavian stenosis | Vascular disorders | Systematic Assessment |
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| Thrombosis in target lesion stenosis/ occlusion | Vascular disorders | Systematic Assessment |
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| Thrombosis of a non-target vessel, contralateral | Vascular disorders | Systematic Assessment |
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| Thrombotic occlusion of a bypass graft | Vascular disorders | Systematic Assessment |
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| Varicose veins | Vascular disorders | Systematic Assessment |
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| Venous insufficiency | Vascular disorders | Systematic Assessment |
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| Venous thrombosis | Vascular disorders | Systematic Assessment |
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| Worsening claudication | Vascular disorders | Systematic Assessment |
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| Worsening of claudication | Vascular disorders | Systematic Assessment |
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| Worsening of PAD | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Dizziness/ lightheadedness | Cardiac disorders | Systematic Assessment |
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| Dyspnea | Cardiac disorders | Systematic Assessment |
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| Edema | Cardiac disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Leg pain and/or cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Numbness and/or tingling in lower extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Skin condition/rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hematoma - Non-index procedure related | Surgical and medical procedures | Systematic Assessment |
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| Stenosis or occlusion in contralateral extremity | Vascular disorders | Systematic Assessment |
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| Stenosis or occlusion in target exremity outside of stent segment | Vascular disorders | Systematic Assessment |
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| Stenosis or occlusion of target lesion within stent segment | Vascular disorders | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Culley, Director of Vascular Intervention | BIOTRONIK | 503-451-8034 | amy.culley@biotronik.com |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Canada |
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| Austria |
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| Belgium |
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| Switzerland |
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| Germany |
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| Hypertension |
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| Hyperlipidemia |
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| Current smoker |
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| Smoked within last 5 years |
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| Never smoked or not within last 5 years |
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| Cerebrovascular disease |
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| History of congestive heart failure |
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| History of ischemic heart disease |
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| History of coronary revasularization |
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| Renal insufficiency |
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| External iliac |
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| Ostial SFA |
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| Proximal SFA |
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| Mid SFA |
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| Distal SFA |
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| Proximal popliteal |
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| Moderate |
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| Severe |
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| Post-deployment Minimum Lumen Diameter (MLD) |
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| Reference vessel diameter |
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| 0 Vessel |
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| 1 Vessel |
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| 2 Vessel |
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| 3 Vessel |
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| Type B |
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| Type C |
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| Type D |
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| OG003 |
| Pulsar Stent Group - Non-occlusive Lesion |
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis). |
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| OG003 | Pulsar Stent Group - Non-occlusive Lesion | Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis). |
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| OG003 | Pulsar Stent Group - Non-occlusive Lesion | Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis). |
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| OG003 | Pulsar Stent Group - Non-occlusive Lesion | Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis). |
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| Pulsar Stent Group - Non-occlusive Lesion |
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis). |
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| Pulsar Stent Group - Non-occlusive Lesion |
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis). |
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