Study ID: TRANSCEND
This randomized clinical trial seeks to explore the safety and efficacy of the investigational SurVeil drug-coated balloon (DCB) and compare it to the FDA-approved IN.PACT Admiral DCB. The patient populations most suitable for this trial are those who have been diagnosed with peripheral artery disease (PAD) and require treatment of a narrowing within an artery in the thigh.
Eligible patients enrolled in the study will be randomized to receive either the SurVeil DCB or the IN.PACT Admiral DCB.
This prospective, multi-center, randomized, single-blind clinical trial is comparing the investigational SurVeil DCB with the IN.PACT Admiral DCB for treatment of patients with Rutherford classification 2, 3 or 4 due to femoral and/or popliteal arterial disease. The SurVeil DCB uses two coatings meant to improve efficiency and uniformity of paclitaxel-drug transfer to the targeted lesion relative to currently available DCBs. Patients with stenosed femoral and/or popliteal artery will be randomized 1:1 to the SurVeil or IN.PACT Admiral DCB and followed for 60 months.
Eligible patients must not have acute limb ischemia. Additionally, patients must not have undergone:
- Intervention involving the target vessel within the previous 90 days
- Any lower extremity percutaneous treatment in the ipsilateral limb using a paclitaxel-eluting stent or a DCB within the previous 90 days
- PTA of the target lesion using a DCB within the previous 180 days
Other inclusion/exclusion criteria apply.
- Must have been diagnosed with peripheral artery disease and in need of interventional treatment with a drug-coated balloon
- Must agree to follow-up care for 60 months