NCT03241459

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

Randomized & Controlled Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: SurModics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.

Detailed description

TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled, noninferiority clinical trial. The trial will randomize approximately 446 subjects with symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the IN.PACT Admiral DCB, and followed for 60 months.

Conditions

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Artery Disease, Peripheral
• Femoropopliteal Artery Occlusion

Interventions

Type	Name	Description
DEVICE	Surmodics SurVeil DCB	Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
DEVICE	Medtronic IN.PACT Admiral DCB	Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Timeline

• Start date: 2017-10-23
• Primary completion: 2020-09-15
• Completion: 2024-09-17
• First posted: 2017-08-07
• Last updated: 2025-03-25
• Results posted: 2024-04-09

Locations

63 sites across 9 countries: United States, Australia, Austria, Belgium, Czechia, Germany, Italy, Latvia, New Zealand

Regulatory

• FDA-regulated device study