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

April 24, 2026 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Groupe hospitalier mutualiste de Grenoble
      • Nantes, France, 44000
        • L'Hôpital Privé du Confluent
      • Toulouse, France, 31300
        • Clinique Pasteur
  • Georgia
      • Tbilisi, Georgia, 0159
        • Tbilisi Heart And Vascular Clinic
      • Tbilisi, Georgia
        • Georgian Israeli Research Medical Centre Helsicore
  • Lithuania
      • Vilnius, Lithuania, 08410
        • Vilniaus universiteto ligoninė Santaros klinikos
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
  3. Subject must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, IVUS/OCT and examinations.

Angiographic Inclusion Criteria

  1. Target lesion must be located within a stent (bare metal or drug eluting) placed in a native epicardial coronary vessel with visually estimated nominal vessel diameter of ≥2.0mm and ≤3.5mm.
  2. Target lesion must measure ≤24 mm in length by visual estimation.
  3. The target lesion must be with a visually estimated stenosis of ≥50% and < 100% with a TIMI flow of ≥1.
  4. Non-clinical investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥90 days prior to or planned to be done 6 months after the index procedure.
  5. Non-clinical investigation, percutaneous intervention for lesions in the target vessel is allowed if planned to be done 6 months after the index procedure.

Exclusion Criteria:

  1. Subject with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure and CK-MB or troponin have not returned within normal limits at the time of procedure.
  2. The subject is currently experiencing clinical symptoms consistent with AMI.
  3. Subject has current unstable arrhythmia.
  4. Subject has a known left ventricular ejection fraction (LVEF) <25%.
  5. Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine and structurally related compounds, everolimus, or contrast sensitivity that cannot be adequately pre-medicated.
  6. Subject has known renal insufficiency (e.g., serum creatinine > 2.5 mg/dL, (i.e. 221 µmol/L) within 7 days prior to index procedure or creatinine clearance <30mL/min or subject is on dialysis.
  7. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  8. Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months.
  9. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
  10. Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
  11. Subject is not, in the opinion of the investigator, an acceptable candidate to participate in the study.
  12. In-stent lesions for stent are located within an arterial or saphenous vein graft or stent used to treat a previous ISR.
  13. The target vessel contains visible thrombus.
  14. Pregnant or lactating females.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug eluting balloon
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Device: Drug Eluting Balloon
PCI of in-stent restenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
Time Frame: 6 months post-index procedure
Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
6 months post-index procedure
The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL)
Time Frame: 180 days post-procedure
In-Stent Late Lumen Loss (LLL) measures the reduction in the luminal diameter of a stented artery over a specified period after stent implantation, typically assessed using angiographic imaging. The unit of measurement for this outcome is expressed in millimeters (mm) or percentage (%), depending on the reporting method. The LLL is calculated by comparing the luminal diameter at a follow-up time point to the post-procedure luminal diameter.
180 days post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Vascular Access Site Complications
Time Frame: 12 months
The rate of vascular access site complications is defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair, transfusion or a prolonged hospital stay or requiring a new hospital admittance.
12 months
Lesion Success:
Time Frame: 12 months
Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of <30% (by QCA), using any device after wire passage through the lesion.
12 months
Technical Success
Time Frame: 12 months
Technical success, defined as achievement of a final in-lesion residual diameter stenosis of <30% (by QCA), using the CVT Everolimus coated PTCA Catheter without a device malfunction after wire passage through the lesion.
12 months
Clinical Success (Per Subject)
Time Frame: 12 months
Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure.
12 months
Procedural Success
Time Frame: 12 months
Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure.
12 months
Composite Rate of Target Lesion Failure (TLF)
Time Frame: 30 days post-procedure, 12 months, 24 months and 36 months
TLF is defined as composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
30 days post-procedure, 12 months, 24 months and 36 months
Composite Rate of Target Vessel Failure (TVF)
Time Frame: 30 days post-procedure, 180 days, 12 months, 24 months and 36 months
Target vessel failure (TVF) is defined as composite rate of cardiovascular death, target vessel myocardial infarction, and target vessel revascularization (TVR).
30 days post-procedure, 180 days, 12 months, 24 months and 36 months
Clinically Driven Target Lesion Revascularization (TLR)
Time Frame: 12 months, 24 months and 36 months
TLR is defined as any repeat PCI of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
12 months, 24 months and 36 months
Clinically-driven Target Vessel Revascularization (TVR)
Time Frame: 180 days, 12 months, 24 months and 36 months
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
180 days, 12 months, 24 months and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Actual)

September 19, 2022

Study Completion (Actual)

May 8, 2025

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TP1125

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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