Peripheral Arterial Disease, Peripheral Artery Disease, Stenosis Artery
Conditions
Brief summary
The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.
Detailed description
This is a prospective, multi-center, non-randomized, single-arm early feasibility study designed to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter for the treatment of stenosis in the femoropopliteal arteries. Follow-up for all treated subjects will be performed at post-procedure, 30 days, and 6, 12 months, 18 months and 24 months post-index procedure.
Interventions
DEVICEBD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty
The study will enroll patients presenting with clinical evidence of an angiographically significant lesion (Lesion ≥ 70% stenosis by visual estimate) in the femoropopliteal arteries. Eligible patients will undergo percutaneous transluminal angioplasty with the investigational BD™ Sirolimus Drug Coated Balloon Catheter.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Pre-Operative Inclusion Criteria: 1. ≥18 years of age. 2. Rutherford Clinical Category 2-4. 3. Participant is willing to provide informed consent, is geographically stable, comply with the required follow up visits and testing schedule and recommended medication regimen. 4. Women of childbearing potential who have a negative UPT at screening. Angiographical Inclusion Criteria: 5. One Lesion of ≥ 3 cm and ≤ 17 cm in length (if two discrete lesions are separated by ≤ 3 cm, but both falling within a composite length of ≤ 17 cm, they may be treated as one lesion). 6. Lesion ≥70% stenosis by visual estimate. 7. Lesion location starts ≥1 cm below the common femoral bifurcation and terminates above the distal P2 segment (top of the tibial plateau). 8. De novo or non-stented restenotic lesion(s) in native femoropopliteal arteries \>90 days from prior interventional procedure. 9. Lesion is located at least 3 cm from any stent. 10. Target reference vessel diameter of 5-6 mm and able to be treated with available device size matrix. 11. Successful, uncomplicated (without use of crossing device, specialty 035 guidewires are acceptable) antegrade wire crossing of lesion. 12. Successful vessel preparation of the target lesion. Successful vessel preparation is defined by successful pre-dilatation to nominal of the target lesion, in the absence of early recoil, significant residual stenosis ≤30% as confirmed by angiography without any major vascular complications or flow-limiting dissections. 13. A patent inflow artery free from significant lesion stenosis (≥50% stenosis) as confirmed by standard of care imaging and the discretion of the investigator Only treatment of ipsilateral iliac inflow arteries is acceptable before the treatment of the target lesion, defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication. 14. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography, that has not previously been revascularized (outflow to be assessed after successful vessel preparation of target lesion; treatment of outflow disease is NOT permitted during the index procedure).
Exclusion criteria
Pre-Operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late lumen loss at six months as measured by quantitative vascular angiography (QVA). | at 6 month follow-up | Late lumen loss is defined as the difference (in mm) between the minimum lumen diameter (MLD) of the treated segment at follow up and the measurement immediately after the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Improvement | at post-procedure, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
| Freedom of Embolization | at discharge, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
| ABI Improvement | at discharge, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
| Revascularization rate (CD-TLR) | at discharge, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
| Rutherford Improvement | at discharge, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
| All Cause Death statistical analyses associated with them but will be reported upon in the final study report. | at discharge, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
| Major Adverse Cardiovascular Events (MACE) statistical analyses associated with them but will be reported upon in the final study report. | at discharge, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
| Safety Composite statistical analyses associated with them but will be reported upon in the final study report. | at discharge, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
| Technical & Procedural Success statistical analyses associated with them but will be reported upon in the final study report. | at discharge, and 1, 6, 12 and 24 month follow-up | This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report. |
Countries
Australia, New Zealand, Singapore
Outcome results
None listed