NCT05734157

CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery

Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.

Detailed description

The CVT-SFA Trial is a prospective, multi-center, open, single arm study enrolling subjects with de-novo or post-PTA occluded/stenotic or re-occluded/ restenotic lesions (excluding in-stent lesions) ≤150mm in length in femoropopliteal arteries with reference vessel diameters of 4-6mm, receiving up to two (2) CVT Everolimus-coated PTA Catheters to establish blood flow and to maintain vessel patency.

Conditions

• Femoral Artery Stenosis
• Popliteal Artery Stenosis
• Femoral Artery Occlusion
• Popliteal Artery Occlusion

Interventions

Type	Name	Description
DEVICE	Peripheral PTA with a drug coated balloon	Peripheral artery angioplasty

Timeline

• Start date: 2022-02-17
• Primary completion: 2023-09-11
• Completion: 2025-08-27
• First posted: 2023-02-17
• Last updated: 2025-09-19
• Results posted: 2025-08-07

Locations

8 sites across 2 countries: France, Germany