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IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).
This study is a prospective, single-arm (non-randomized), post-market study which will enroll up to 25 subjects. Intravascular Ultrasound (IVUS) imaging and angiography will be used to assess procedural outcomes in patients who have symptomatic peripheral artery disease who are treated with the Sponsor's OAS and adjunctive balloon angioplasty. An independent IVUS Core Lab will be used to provide adjudicated analyses for IVUS outcomes. In clinic follow-up visits will be performed at 2 weeks, 6 months and at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OAS + BA | Other | Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stealth 360°® OAS | Device | Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Clinically Driven Target Lesion Revascularization (TLR) | A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months. | 6 months and 12 months |
| Mean Maximum Balloon Inflation Pressure | Mean maximum balloon inflation pressure of balloons used pre-stent placement. | Index Procedure |
| Rate of Procedural Angiographic Complications | Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil). | Index Procedure |
| Ankle-Brachial Index (ABI) Measurments | The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel. | Baseline, 2 weeks, 6 months and 12 months |
| Rutherford Classification (RC) | Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit. RC classification is as follows: RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anvar Babaev, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26490645 | Result | Babaev A, Zavlunova S, Attubato MJ, Martinsen BJ, Mintz GS, Maehara A. Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study). Vasc Endovascular Surg. 2015 Oct;49(7):188-94. doi: 10.1177/1538574415607361. Epub 2015 Oct 20. | |
| 27864454 | Result | Krishnan P, Martinsen BJ, Tarricone A, Babaev A, Maehara A. Minimal Medial Injury After Orbital Atherectomy. J Endovasc Ther. 2017 Feb;24(1):167-168. doi: 10.1177/1526602816678033. Epub 2016 Nov 19. No abstract available. |
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CSI has no plans to share IPD with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Stealth 360°® OAS | Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 2 Week Follow up |
| |||||||||||||
| 6 Month Follow up |
| |||||||||||||
| 12 Month Follow up |
|
Subjects with symptomatic peripheral artery disease
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| ID | Title | Description |
|---|---|---|
| BG000 | Stealth 360°® OAS | Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Clinically Driven Target Lesion Revascularization (TLR) | A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months. | Posted | Number | 95% Confidence Interval | % probablity of clinically driven TLR | 6 months and 12 months |
|
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AEs were collected during the index-procedure through 12 months of follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stealth 360°® OAS | Cardiovascular Systems Inc.'s Orbital Atherectomy System (OAS), is used prior to adjunctive balloon angioplasty (BA) Stealth 360°® OAS: Cardiovascular Systems Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding, access site | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dissection | Injury, poisoning and procedural complications | Non-systematic Assessment | All dissections were non-flow limiting |
TRUTH was a single center, non-randomized trial that enrolled a small number of subjects (25).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anvar Babaev, MD, PHD, FACC, FSCAI | NYU Langone Medical Center | 212-263-5656 | anvar.babaev@nyumc.org |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Baseline, 2 weeks, 6 month and 12 month |
| Stent Usage at the Time of the Index Procedure | Number of lesions with a stent placed during the index procedure. | Index Procedure |
| Percent (%) Area Stenosis | Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area). | Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment) |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of treated lesions | Number | lesions |
|
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| Primary | Mean Maximum Balloon Inflation Pressure | Mean maximum balloon inflation pressure of balloons used pre-stent placement. | Posted | Mean | Standard Deviation | atm | Index Procedure | balloons | balloons |
|
|
|
| Primary | Rate of Procedural Angiographic Complications | Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil). | Posted | Count of Participants | Participants | Index Procedure |
|
|
|
| Primary | Ankle-Brachial Index (ABI) Measurments | The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel. | At the time of this analysis 3 of the subjects did not have their ABI measured at baseline, 1 participant did not have their ABI measured at 2 weeks, 1 participant did not have their ABI measured at 6 months and 1 participant did not have their ABI measured at 12 months. | Posted | Mean | Standard Deviation | ratio | Baseline, 2 weeks, 6 months and 12 months |
|
|
|
| Primary | Rutherford Classification (RC) | Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit. RC classification is as follows: RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable | At the time of analysis for the 6 month visit 1 participant missed their follow up visit. At the time of analysis for the 12 month visit, 22 participants completed the 12 month follow up visit. | Posted | Count of Participants | Participants | Baseline, 2 weeks, 6 month and 12 month |
|
|
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| Primary | Stent Usage at the Time of the Index Procedure | Number of lesions with a stent placed during the index procedure. | Number of stents placed is based on number of lesions treated in the total subject population of 25. The total number of lesions treated were 29 and of those 29 lesions, 17 had a stent placed. | Posted | Number | Lesions | Index Procedure | Lesions | Lesions |
|
|
|
| Primary | Percent (%) Area Stenosis | Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area). | At the time of analysis 24 of 29 lesions in 25 participants could be assess by the IVUS Core Lab. | Posted | Median | Inter-Quartile Range | percent area stenosis | Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment) | lesions | lesions |
|
|
|
| 0 |
| 25 |
| 10 |
| 25 |
| 11 |
| 25 |
| Distal Embolization | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dissection | Injury, poisoning and procedural complications | Non-systematic Assessment | All dissections were non-flow limiting |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
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| Worsening of PAD | Vascular disorders | Non-systematic Assessment |
|
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| Worsening of PAD | Vascular disorders | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Distal embolization |
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| Recoil |
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| ABI at 6 months |
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| ABI at 12 months |
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| RC 0 at 6 month |
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| RC 0 at 12 month |
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| RC 1 at baseline |
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| RC 1 at 2 weeks |
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| RC 1 at 6 month |
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| RC 1 at 12 months |
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| RC 2 at baseline |
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| RC 2 at 2 weeks |
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| RC 2 at 6 month |
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| RC 2 at 12 months |
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| RC 3 at baseline |
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| RC 3 at 2 weeks |
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| RC 3 at 6 month |
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| RC 3 at 12 months |
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