CVT-ISR First in Human Trial for Coronary In-Stent Restenosis

Status Active, not recruiting

Clinical Trial Summary

The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.

Clinical Trial Description

The CVT-ISR Trial is a prospective, multi-center, open, single arm study enrolling subjects with visually estimated nominal vessel diameter ≥2.0 mm and ≤3.5mm and lesion length ≤24 mm receiving up to two (2) CVT Everolimus CVT EVE-PTCA Catheters. An angiographic follow up, in combination with either Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), follow-up, will be carried out in a subset of 25 patients at 180 days following the index procedure. ;

Study Design

Related Conditions & MeSH terms

In-stent Restenosis

Clinical Trial Details

NCT number	NCT05731700
Study type	Interventional
Source	Chansu Vascular Technologies
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 20, 2021
Completion date	April 21, 2025

View Details

See also
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