CompletedNot Applicable

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

Australia34 participantsStarted 2022-08-02

Plain-language summary

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

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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.

✕. ≥ 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.

Late lumen loss at six months as measured by quantitative vascular angiography (QVA).

Timeframe: at 6 month follow-up

NCT IDNCT05556681

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-12

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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.

✕. ≥ 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.