NCT05731700

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

Everolimus-Coated Percutaneous Transluminal Coronary Angioplasty Catheter First in Human Clinical Investigation: A Clinical Evaluation in the Treatment of Subjects With In-Stent Restenosis of Previously-treated Coronary Artery Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• In-stent Restenosis

Interventions

Type	Name	Description
DEVICE	Drug Eluting Balloon	PCI of in-stent restenosis

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-09-19
• Completion: 2025-05-08
• First posted: 2023-02-16
• Last updated: 2025-09-19
• Results posted: 2025-05-15

Locations

9 sites across 4 countries: France, Georgia, Lithuania, Spain