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

NCT05556681 | Completed FDA Device

• 1 other identifier: BDPI-20-012
• Study Type: interventional
• Target: 34
• Locations: 3 countries
• Sites: 10

Brief Summary

The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.

Conditions

Peripheral Arterial Disease; Peripheral Artery Disease; Stenosis Artery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Rutherford Improvement

  at discharge, and 1, 6, 12 and 24 month follow-up

• Patient Reported Outcome Improvement

  at post-procedure, and 1, 6, 12 and 24 month follow-up

• Freedom of Embolization

  at discharge, and 1, 6, 12 and 24 month follow-up

• ABI Improvement

  at discharge, and 1, 6, 12 and 24 month follow-up

• Revascularization rate (CD-TLR)

  at discharge, and 1, 6, 12 and 24 month follow-up

Study Arms (1)

Treated with the investigational BD™ Sirolimus Drug Coated Catheter

EXPERIMENTAL

Patients treated with the BD™ Sirolimus Drug Coated Catheter

Device: BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty

Interventions

BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty DEVICE

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.

Treated with the investigational BD™ Sirolimus Drug Coated Catheter

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age.
• Rutherford Clinical Category 2-4.
• Participant is willing to provide informed consent, is geographically stable, comply with the required follow up visits and testing schedule and recommended medication regimen.
• Women of childbearing potential who have a negative UPT at screening.
• 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 above the distal P2 segment (top of 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 guidewires 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).

You may not qualify if:

• ≥ 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 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 lesion.
• 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 immune-modifying 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).

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (10)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Flinders University

Adelaide, South Australia, 5001, Australia

Location

The Alfred

Melbourne, Victoria, 3004, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

Location

Waikato Hospital

Hamilton, Waikato Region, 3204, New Zealand

Location

Tan Tock Seng Hospital

Novena, 308433, Singapore

Location

Sengkang General Hospital

Punggol, 544886, Singapore

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Talar Saber

  Becton, Dickinson and Company (BD) (CRBARD)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 27, 2022
• Study Start: August 2, 2022
• Primary Completion: June 12, 2024
• Study Completion: November 24, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); SG (2); AU (6)