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This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic PAD.
The primary objective of the clinical investigation is to evaluate the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries (SFA/PA) of patients with symptomatic PAD.
The performance of the GORE® DCB Catheter is superior to a performance goal derived from literature reports of uncoated PTA balloons, measured six months after intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Coated Balloon | Experimental | Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Coated Balloon | Device | Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss (LLL) | Six month late lumen loss (LLL) is defined as the difference in minimum lumen diameter of the Target lesion between the time points immediately post-intervention and the 6-month follow-up angiography or at the time of a Clinically Driven Target Lesion Revascularization (CD TLR), whichever is earlier. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Freedom From Major Adverse Events | A composite 30-day safety endpoint of freedom from Major Adverse Events (MAE), defined as i) death, ii) Clinically-Driven Target Vessel Revascularization (CD TVR), or iii) amputation above the metatarsals, resulting from a vascular event, in the treated leg (Target limb amputation). | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitats - Herzzentrum Freiburg | Bad Krozingen | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug Coated Balloon | Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug Coated Balloon | Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Late Lumen Loss (LLL) | Six month late lumen loss (LLL) is defined as the difference in minimum lumen diameter of the Target lesion between the time points immediately post-intervention and the 6-month follow-up angiography or at the time of a Clinically Driven Target Lesion Revascularization (CD TLR), whichever is earlier. | Of the 44 subjects completed the study, the late lumen loss was only available for 37 subjects, rest were treated as missing data. | Posted | Mean | Standard Deviation | mm | Six months |
|
2 Years
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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 | Drug Coated Balloon | Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulation disorder | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post angioplasty restenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rizwan Afzal | W. L. Gore and Associates | 6236404888 | rafzal@wlgore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2017 | Nov 10, 2022 | Prot_SAP_000.pdf |
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| Surgical bypass |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean Lesion Diameter Post Procedure(mm) | The lesion diameter at the completion of the procedure is used as baseline from which the loss was calculated at six months. | Mean | Standard Deviation | milimeters |
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| Secondary | Number of Subjects With Freedom From Major Adverse Events | A composite 30-day safety endpoint of freedom from Major Adverse Events (MAE), defined as i) death, ii) Clinically-Driven Target Vessel Revascularization (CD TVR), or iii) amputation above the metatarsals, resulting from a vascular event, in the treated leg (Target limb amputation). | Posted | Count of Participants | Participants | 30 days |
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| 1 |
| 52 |
| 27 |
| 52 |
| 13 |
| 52 |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Mitral valve insufficiency | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Multiple vessel coronary artery disease | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Non STEMI | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Triple vessel disease | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Cataract (right) | Eye disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Esophagitis ulcerative | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Aspiration pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| Perineal abscess | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| Fracture of pelvis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Fractured ribs | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Lumbar vertebral fracture L3 | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Peripheral arterial reocclusion | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Post angioplasty restenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Second degree burns | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Shoulder fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Superficial femoral arterial restenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Diabetes mellitus aggravated | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Limb hyperextension | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Basal cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
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| Bleeding intracranial | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Nerve root impingement | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Vaginal prolapse | Reproductive system and breast disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Adventitial cystic disease | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Femoral artery dissection | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Femoral artery stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Femoropopliteal stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Iliac artery dissection | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Iliac artery stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Peripheral artery dissection | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Peripheral artery occlusion | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Superficial femoral arterial restenosis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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