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

Femoral Artery Occlusion Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05734157
Study type Interventional
Source Chansu Vascular Technologies
Contact
Status Active, not recruiting
Phase N/A
Start date February 17, 2022
Completion date September 1, 2025
View Details
See also
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