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| Name | Class |
|---|---|
| Syntactx | NETWORK |
| PQ Bypass, Inc. | INDUSTRY |
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The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.
Peripheral Arterial Disease, specifically in the superficial femoral arteries (SFA) and proximal popliteal arteries, are treated by a range of alternative practices and procedures for the patient population identified in the indications for use statement. Non-invasive approaches include exercise and drug therapy.
Minimally-invasive approaches include endovascular intervention using percutaneous transluminal angioplasty using a plain or drug-coated balloon, stents (bare metal, drug-eluting and covered) and various modalities of atherectomy.
SFA Stent Graft Systems have a clinical history that demonstrates that this device type is well understood, and the benefits and risks are well-characterized, i.e. mature technology.
Endologix believes that the clinical performance of the TORUS stent would be comparable to marketed SFA Stent Graft System. The TORUS 2 IDE Clinical Study will confirm this and is designed to demonstrate the safety and effectiveness of the TORUS Stent Graft System in patients with SFA and/or proximal popliteal artery disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TORUS Stent Graft System | Experimental | The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORUS Stent Graft System | Device | The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From a Major Adverse Event (MAE) | An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) | 30 days |
| Primary Patency | Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30% | At the time of the index procedure |
| Procedural Success | Procedural Success is defined as technical success with out any MAEs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehrin Armstrong,, MD | Denver Veteran's Administration Hospital | Principal Investigator |
| Peter Schneider,, MD | University of California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest CVA | Mesa | Arizona | 85206 | United States | ||
| Vascular Heart & Lung Associates |
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The TORUS 1 clinical study was conducted in Germany and Latvia and enrolled a total of 60 subjects. Subject enrollment for TORUS 1 was closed on July 1, 2019. As per the TORUS 2 Statistical Analysis Plan (SAP) version 2, the last 30 subjects enrolled in TORUS 1 study are included in the endpoint analysis for the TORUS 2 study. Subject 30 in the TORUS 1 study was rolled-over into the TORUS 2 cohort, and was enrolled on August 13, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | TORUS Stent Graft System | The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS). TORUS Stent Graft System: The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2020 | Dec 12, 2025 |
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|
|
| Within 24 hours of the procedure |
| Major Adverse Event (MAE) Rate | Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR). | 12 months |
| Major Amputation on Target Limb | Major Amputation on Target Limb were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months | Through 36 months |
| Patency Rate | Absence of CD-TLR and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5. | Through 12 months |
| Clinically Driven Target Lesion Revascularization | Clinically Driven Target Lesion Revascularization were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months | Through 36 months |
| Walking Improvement Questionnaire (WIQ) Assessment | Walking Impairment Questionnaire (WIQ) - The WIQ is a patient-reported outcome measure that assesses self-reported walking ability in individuals with peripheral arterial disease (PAD). It evaluates perceived difficulty performing walking tasks related to walking distance, walking speed, and stair climbing, which reflect functional limitations caused by PAD. Scale Structure and Scoring: The WIQ consists of three subscales: Walking Distance Walking Speed Stair Climbing Each subscale is scored from 0 to 100, where higher scores indicate better walking function. The Composite PAD Score (PADSCORE) is calculated by averaging the three subscale scores, resulting in a total composite score ranging from 0 to 100. Scale Ranges and Interpretation: WIQ Subscale Scores: 0 (worst function) to 100 (best function) WIQ Composite PAD Score: 0 (worst walking impairment) to 100 (no walking impairment) Direction of Outcome: For all WIQ scores, higher values represent a better outcome | Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M) |
| Quality of Life Assessment by the EQ5D VAS | EuroQol Visual Analog Scale (EQ-5D-VAS) - The EQ-5D-VAS is a patient-reported outcome measure that assesses overall self-rated health-related quality of life. Participants rate their current health status using a visual analog scale anchored by the best and worst imaginable health states. Scale Structure and Scoring: Participants mark their perceived health status on a vertical visual analog scale. Scale Range and Interpretation: EQ-5D-VAS Score Range: 0 to 100 0: Worst imaginable health state (minimum) 100: Best imaginable health state (maximum) Direction of Outcome: Higher EQ-5D-VAS scores represent a better outcome, reflecting better perceived health-related quality of life. Lower scores indicate worse perceived health status. Unit of Measure: EQ-5D-VAS (scores on a scale) | Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M) |
| Stent Fracture Rate | Stent fracture rate using VIVA definitions | 12 months |
| Change in Ankle-Brachial Index | Change in Ankle-Brachial Index (ABI) in study subjects from baseline to each study interval through follow-up. Scale Structure and Scoring: Change in ABI was calculated as the difference between post-baseline ABI and baseline ABI for each participant for the target limb. ABI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Therefore, interpretation is based on clinically established thresholds rather than absolute scale limits: ABI ≤ 0.90: Consistent with peripheral arterial disease ABI 0.91-1.29: Generally considered normal arterial perfusion ABI ≥ 1.30: Suggestive of non-compressible arteries (e.g., arterial calcification) Change in ABI: Positive change (increase): Improvement in lower-extremity perfusion Negative change (decrease): Worsening arterial perfusion Direction of Outcome: For Change in ABI, higher (more positive) values represent a better outcome | Change from Baseline through 36 months |
| Change in Toe Pressures | Change in Toe-Brachial Index (TBI) in study subjects from baseline to each study interval through follow-up for the target limb. If ABI could not be assessed the TBI was assessed. Scale Structure and Scoring: TBI is calculated as: TBI = Toe systolic blood pressure ÷ Brachial systolic blood pressure Change in TBI was calculated as the difference between post-baseline TBI and baseline TBI for each participant. Scale Range and Clinical Interpretation: TBI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Interpretation is therefore based on clinically established thresholds rather than absolute scale limits: TBI < 0.70: Consistent with peripheral arterial disease TBI ≥ 0.70: Generally considered normal digital perfusion For Change in TBI: A positive change (increase) indicates improvement in distal (digital) perfusion A negative change (decrease) indicates worsening arterial perfusion | Change from Baseline through 36 months |
| Change in Rutherford Clinical Classification | Clinical success: improvement in ≥ 1 Rutherford class | From procedure through 36 months |
| Mesa |
| Arizona |
| 85206 |
| United States |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85018 | United States |
| Yuma Cardiology Associates | Yuma | Arizona | 85349 | United States |
| Arkansas Heart | Little Rock | Arkansas | 72211 | United States |
| Bay Area Vein & Vascular Institute | Burlingame | California | 94010 | United States |
| UCSF | San Francisco | California | 94143 | United States |
| Rocky Mountain Regional VAMC | Aurora | Colorado | 80045 | United States |
| The Vascular Experts | Darien | Connecticut | 06820 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | United States |
| Palm Vascular Centers | Miami Beach | Florida | 33140 | United States |
| Coastal Vascular & Interventional | Pensacola | Florida | 32504 | United States |
| Florida Cardiology | Winter Park | Florida | 32792 | United States |
| AMITA Health | Elk Grove | Illinois | 60007 | United States |
| MedStar Health Research Insitute | Hyattsville | Maryland | 20782 | United States |
| McLaren Bay Region | Bay City | Michigan | 48708 | United States |
| Michigan Vascular Center | Flint | Michigan | 48507 | United States |
| Eastlake Cardiovascular | Roseville | Michigan | 48066 | United States |
| Northern Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Novant Health | Charlotte | North Carolina | 28204 | United States |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | United States |
| The Lindner Center for Research & Education | Cincinnati | Ohio | 45219 | United States |
| Naadi | Oklahoma City | Oklahoma | 73116 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Prisma Health | Greenville | South Carolina | 29615 | United States |
| North Central Heart | Sioux Falls | South Dakota | 57108 | United States |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |
| Texas Tech | Lubbock | Texas | 79430 | United States |
| North Dallas Research Associates | McKinney | Texas | 75069 | United States |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | United States |
| Bellin Hospital | Green Bay | Wisconsin | 54301 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
A total of 188 subjects (TORUS 2: 158 and TORUS 1: 30) were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | TORUS Stent Graft System | TORUS 2 is a multi-center, single arm, non-randomized, prospective clinical study using the TORUS Stent Graft for treatment of atherosclerotic lesions within the superficial femoral artery (SFA) and/or popliteal artery. TORUS 1 a multi-center, single arm, non-randomized, prospective clinical study using the TORUS Stent Graft in the EU. A total of 60 subjects have been enrolled in the TORUS 1 study. Of the 60 subjects enrolled, data from the last 30 subjects (enrolled across 6 sites) have been included in this report of TORUS 2. TORUS 1 study follow up data ended at 24 months follow up visit. 36-month data is provided with only TORUS 2 study subjects. A total of 188 subjects (TORUS 2: 158 and TORUS 1: 30) were reported on below: |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | A total of 188 subjects (TORUS 2: 158 and TORUS 1: 30) were enrolled. Ethnicity not collected for TORUS 1 subjects. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | A total of 188 subjects (TORUS 2: 158 and TORUS 1: 30) were enrolled. Race not collected for TORUS 1 subjects. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| History of Renal Insufficiency | Count of Participants | Participants |
| ||||||||||||||||||
| History of Smoking | Count of Participants | Participants |
| ||||||||||||||||||
| Diabetes Mellitus | Count of Participants | Participants |
| ||||||||||||||||||
| History of MI | Count of Participants | Participants |
| ||||||||||||||||||
| History of CAD | Count of Participants | Participants |
| ||||||||||||||||||
| History of Hyperlipidemia | Count of Participants | Participants |
| ||||||||||||||||||
| History of Hypertension | Count of Participants | Participants |
| ||||||||||||||||||
| History of Peripheral Intervention | Count of Participants | Participants |
| ||||||||||||||||||
| History of Peripheral Vascular Surgery | Count of Participants | Participants |
| ||||||||||||||||||
| Rutherford Classification | Clinical severity of peripheral arterial disease (PAD) was assessed using the Rutherford classification system, which stages disease based on symptoms and presence of tissue loss. Participants were categorized as follows: Category 0: Asymptomatic Category 1: Mild claudication Category 2: Moderate claudication Category 3: Severe claudication Category 4: Ischemic rest pain Category 5: Minor tissue loss (ischemic ulceration) Category 6: Major tissue loss (gangrene) Higher Rutherford categories represent worse clinical status. | Count of Participants | 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 | Freedom From a Major Adverse Event (MAE) | An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) | Posted | Count of Participants | Participants | 30 days |
|
|
| |||||||||||||||||||||||||||
| Primary | Primary Patency | Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Technical Success | Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30% | Posted | Count of Participants | Participants | At the time of the index procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | Procedural Success | Procedural Success is defined as technical success with out any MAEs. | Posted | Count of Participants | Participants | Within 24 hours of the procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | Major Adverse Event (MAE) Rate | Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR). | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Major Amputation on Target Limb | Major Amputation on Target Limb were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months | TORUS 1 data not collected at 36-month | Posted | Count of Participants | Participants | Through 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Patency Rate | Absence of CD-TLR and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5. | Posted | Count of Participants | Participants | Through 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Clinically Driven Target Lesion Revascularization | Clinically Driven Target Lesion Revascularization were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months | TORUS 1 data not collected at 36-month | Posted | Count of Participants | Participants | Through 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Walking Improvement Questionnaire (WIQ) Assessment | Walking Impairment Questionnaire (WIQ) - The WIQ is a patient-reported outcome measure that assesses self-reported walking ability in individuals with peripheral arterial disease (PAD). It evaluates perceived difficulty performing walking tasks related to walking distance, walking speed, and stair climbing, which reflect functional limitations caused by PAD. Scale Structure and Scoring: The WIQ consists of three subscales: Walking Distance Walking Speed Stair Climbing Each subscale is scored from 0 to 100, where higher scores indicate better walking function. The Composite PAD Score (PADSCORE) is calculated by averaging the three subscale scores, resulting in a total composite score ranging from 0 to 100. Scale Ranges and Interpretation: WIQ Subscale Scores: 0 (worst function) to 100 (best function) WIQ Composite PAD Score: 0 (worst walking impairment) to 100 (no walking impairment) Direction of Outcome: For all WIQ scores, higher values represent a better outcome | Posted | Mean | Standard Deviation | PADSCORE | Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M) |
| ||||||||||||||||||||||||||||
| Secondary | Quality of Life Assessment by the EQ5D VAS | EuroQol Visual Analog Scale (EQ-5D-VAS) - The EQ-5D-VAS is a patient-reported outcome measure that assesses overall self-rated health-related quality of life. Participants rate their current health status using a visual analog scale anchored by the best and worst imaginable health states. Scale Structure and Scoring: Participants mark their perceived health status on a vertical visual analog scale. Scale Range and Interpretation: EQ-5D-VAS Score Range: 0 to 100 0: Worst imaginable health state (minimum) 100: Best imaginable health state (maximum) Direction of Outcome: Higher EQ-5D-VAS scores represent a better outcome, reflecting better perceived health-related quality of life. Lower scores indicate worse perceived health status. Unit of Measure: EQ-5D-VAS (scores on a scale) | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M) |
| ||||||||||||||||||||||||||||
| Secondary | Stent Fracture Rate | Stent fracture rate using VIVA definitions | Stent fracture by X-ray reported at 12-month for subjects with X-rays completed. 12 Month X-ray data was not a required assessment for the TORUS 1 study. | Posted | Count of Participants | Participants | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Ankle-Brachial Index | Change in Ankle-Brachial Index (ABI) in study subjects from baseline to each study interval through follow-up. Scale Structure and Scoring: Change in ABI was calculated as the difference between post-baseline ABI and baseline ABI for each participant for the target limb. ABI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Therefore, interpretation is based on clinically established thresholds rather than absolute scale limits: ABI ≤ 0.90: Consistent with peripheral arterial disease ABI 0.91-1.29: Generally considered normal arterial perfusion ABI ≥ 1.30: Suggestive of non-compressible arteries (e.g., arterial calcification) Change in ABI: Positive change (increase): Improvement in lower-extremity perfusion Negative change (decrease): Worsening arterial perfusion Direction of Outcome: For Change in ABI, higher (more positive) values represent a better outcome | Posted | Mean | Standard Deviation | Ankle-Brachial Index (ABI) | Change from Baseline through 36 months |
| ||||||||||||||||||||||||||||
| Secondary | Change in Toe Pressures | Change in Toe-Brachial Index (TBI) in study subjects from baseline to each study interval through follow-up for the target limb. If ABI could not be assessed the TBI was assessed. Scale Structure and Scoring: TBI is calculated as: TBI = Toe systolic blood pressure ÷ Brachial systolic blood pressure Change in TBI was calculated as the difference between post-baseline TBI and baseline TBI for each participant. Scale Range and Clinical Interpretation: TBI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Interpretation is therefore based on clinically established thresholds rather than absolute scale limits: TBI < 0.70: Consistent with peripheral arterial disease TBI ≥ 0.70: Generally considered normal digital perfusion For Change in TBI: A positive change (increase) indicates improvement in distal (digital) perfusion A negative change (decrease) indicates worsening arterial perfusion | Posted | Mean | Standard Deviation | Toe-Brachial Index (TBI) | Change from Baseline through 36 months |
| ||||||||||||||||||||||||||||
| Secondary | Change in Rutherford Clinical Classification | Clinical success: improvement in ≥ 1 Rutherford class | data reported on subjects with available data | Posted | Count of Participants | Participants | From procedure through 36 months |
|
|
Adverse Events are reported through 12 months. Serious Adverse events are reported through 12 Months.
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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 | TORUS Stent Graft System | TORUS 2 is a multi-center, single arm, non-randomized, prospective clinical study using the TORUS Stent Graft for treatment of atherosclerotic lesions within the superficial femoral artery (SFA) and/or popliteal artery. TORUS 1 a multi-center, single arm, non-randomized, prospective clinical study using the TORUS Stent Graft in the EU. A total of 60 subjects have been enrolled in the TORUS 1 study. Of the 60 subjects enrolled, data from the last 30 subjects (enrolled across 6 sites) have been included in this report of TORUS 2. TORUS 1 study follow up data ended at 24 months follow up visit. 36-month data is provided with only TORUS 2 study subjects. A total of 188 subjects (TORUS 2: 158 and TORUS 1: 30) were reported on below: | 24 | 188 | 85 | 188 | 136 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eye disorders | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Investigations | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Psychiatric disorders | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Endocrine disorders | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eye disorders | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Investigations | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neoplasms benign, malignant, and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Product issues | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Moawad, Sr. Manager, Clinical Affairs | Endologix LLC | 949-595-7244 | mmoawad@endologix.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2020 | Dec 12, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
|
|
|
|
|
|
|
|
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| Units | Counts |
|---|---|
| Participants |
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|