Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries

Study Overview
=================
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.

Official Title
-----------------
Prospective, Multicenter, Single Arm, Non-Randomized Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries

Conditions
-----------------
Peripheral Arterial Disease, Peripheral Artery Disease, Stenosis Artery

Intervention / Treatment
-----------------
* Device: BD™ Sirolimus Drug Coated Balloon Catheter angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-Operative Inclusion Criteria: ≥18 years of age Rutherford Clinical Category 2-4 Patient is willing to provide informed consent, is geographically stable, comply with the required follow up visits, testing schedule, and recommended medication regimen Women of childbearing potential who have a negative urine pregnancy test (UPT) at screening Angiographical Inclusion Criteria: 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). Lesion ≥70% stenosis by visual estimate Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≥2 cm above the tibial plateau. De novo or non-stented restenotic lesion(s) in native femoropopliteal arteries >90 days from prior interventional procedure Lesion is located at least 3 cm from any stent Target reference vessel diameter of 5-6 mm and able to be treated with available device size matrix Successful, uncomplicated (without use of crossing device, specialty 035 guidewire are acceptable) antegrade wire crossing of lesion 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. 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 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 Exclusion Criteria: ≥ 90 years of age Women who are breastfeeding, currently pregnant or planning to become pregnant during the duration of the study or have a positive urine pregnancy test at screening. Men who are intending to biologically father children during the duration of the study Life expectancy of <2 years Participant has acute limb ischemia Previous treatment of the target limb using Drug Coated Balloon (DCB), a stent, or Drug Eluting Stent (DES) within the last 180 days. Previous treatment of the contralateral limb using Drug Coated Balloon (DCB) or Drug Eluting Stent (DES) within the last 90 days. History of stroke or Transient Ischemic Attack (TIA) within 90 days. History of myocardial infarction (MI), thrombolysis or angina within 30 days of index procedure Renal failure (on dialysis) or chronic kidney disease (Glomerular Filtration Rate (GFR) < 30 ml/min per 1.73m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis)) that in the opinion of the investigator should preclude participant enrollment in the study Active or suspected active infection at time of index procedure that in the opinion of the investigator should preclude participant enrollment in the study Patients with any type of previous or planned surgical or interventional procedure within 30 days prior and/or within 30 days post-index procedure Sudden symptom onset (within two weeks), acute vessel occlusion, or acute or sub-acute thrombus in target vessel or history of treatment of thrombolysis in the target legion Known contraindication (including allergic reaction) or sensitivity to sirolimus (rapamycin). Known contraindication (including reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre- and post-procedure medication. CO2 angiography is not allowed. Has received systemic immunosuppressants or immunemodifying drugs for >14 days in total within 3 months prior to Screening (for corticosteroids ≥ 20 mg/day of prednisone equivalent, excluding standard of care use of inhaled corticosteroids). Immunosuppressive or immunodeficient state, in the opinion of the investigator, that would preclude the participant from being eligible to be treated with a sirolimus DCB. Note: HIV positive participants with CD4 count ≥350 cells/mm3 and an undetectable HIV viral load within the past year [low level variations from 50-500 viral copies which do not lead to changes in antiretroviral therapy [ART] are permitted. Has active malignancy prior to study entry Bleeding diathesis, Gastrointestinal ulceration, another coagulopathy disorder, or allergy in the opinion of the investigator, which would restrict the use of anticoagulant or dual antiplatelet therapy (DAPT) Participant is currently participating in an investigational drug or device study, or previously enrolled in a trial within the last 30 days prior to screening. Enrollment in another investigational drug or device study during the follow up period for this study is not allowed. Current alcohol or drug abuse that in the opinion of the investigator should preclude participant enrollment in the study Participant has a condition that in the opinion of the investigator should preclude participant enrollment in the study Angiographical Exclusion Criteria: Severe Calcification as defined as PARC scoring system (> 180 degrees (both sides of the vessel at the same location) and greater than one-half of the total lesion length) of the target lesion. Intended use of adjunctive primary treatment modalities (e.g., atherectomy, laser, cutting balloons, radiation therapy, stents, other drug coated devices.) Use of reentry devices during the index procedure for antegrade recanalization, which include but are not limited to percutaneous intentional extraluminal recanalization (PIER) and subintimal arterial flossing with antegrade retrograde intervention (SAFARI) techniques.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated with the investigational BD™ Sirolimus Drug Coated Catheter<br>Patients treated with the BD™ Sirolimus Drug Coated Catheter | Device: BD™ Sirolimus Drug Coated Balloon Catheter angioplasty<br>* The study will enroll patients presenting with clinical evidence of an angiographically significant lesion (Lesion ≥ 70% stenosis by visual estimate) in the femoropopliteal arteries. After pre-dilatation, patients will undergo angioplasty with the investigational BD™ Sirolimus Drug Coated Balloon Catheter.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss at six months as measured by quantitative vascular angiography (QVA). | 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. | at 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rutherford Improvement | 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. | at discharge, and 1, 6, 12 and 24 month follow-up | 
| Patient Reported Outcome Improvement | 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. | at post-procedure, and 1, 6, 12 and 24 month follow-up | 
| Freedom of Embolization | 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. | at discharge, and 1, 6, 12 and 24 month follow-up | 
| ABI Improvement | 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. | at discharge, and 1, 6, 12 and 24 month follow-up | 
| Revascularization rate (CD-TLR) | 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. | at discharge, and 1, 6, 12 and 24 month follow-up | 
| Technical & Procedural Success statistical analyses associated with them but will be reported upon in the final study report. | 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. | at discharge, and 1, 6, 12 and 24 month follow-up | 
| All Cause Death statistical analyses associated with them but will be reported upon in the final study report. | 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. | at discharge, and 1, 6, 12 and 24 month follow-up | 
| Major Adverse Cardiovascular Events (MACE) statistical analyses associated with them but will be reported upon in the final study report. | 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. | at discharge, and 1, 6, 12 and 24 month follow-up | 
| Safety Composite statistical analyses associated with them but will be reported upon in the final study report. | 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. | at discharge, and 1, 6, 12 and 24 month follow-up |