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

NCT05731700 | Completed Results

• 1 other identifier: TP1125
• Study Type: interventional
• Target: 51
• Locations: 4 countries
• Sites: 9

Brief 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.

Conditions

In-stent Restenosis

Keywords

TP1125; Coronary; CVT; CVT-ISR

Outcome Measures

Primary Outcomes (2)

• The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate

  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)

  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 Outcomes (9)

• Composite Rate of Target Lesion Failure (TLF)

  30 days post-procedure and 12 months

• Composite Rate of Target Vessel Failure (TVF)

  30 days post-procedure, 180 days and 12 months

• Clinically Driven Target Lesion Revascularization (TLR)

  12 months

• Clinically-driven Target Vessel Revascularization (TVR)

  180 days and 12 months

• Rate of Vascular Access Site Complications

  12 months

Study Arms (1)

Drug eluting balloon

EXPERIMENTAL

Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon

Device: Drug Eluting Balloon

Interventions

Drug Eluting Balloon DEVICE

PCI of in-stent restenosis

Drug eluting balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age.
• 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.
• Subject must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, IVUS/OCT and examinations.
• 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.
• Target lesion must measure ≤24 mm in length by visual estimation.
• The target lesion must be with a visually estimated stenosis of ≥50% and \< 100% with a TIMI flow of ≥1.
• 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.
• Non-clinical investigation, percutaneous intervention for lesions in the target vessel is allowed if planned to be done 6 months after the index procedure.

You may not qualify if:

• 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.
• The subject is currently experiencing clinical symptoms consistent with AMI.
• Subject has current unstable arrhythmia.
• Subject has a known left ventricular ejection fraction (LVEF) \<25%.
• 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.
• 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.
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months.
• 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).
• Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
• Subject is not, in the opinion of the investigator, an acceptable candidate to participate in the study.
• In-stent lesions for stent are located within an arterial or saphenous vein graft or stent used to treat a previous ISR.
• The target vessel contains visible thrombus.
• Pregnant or lactating females.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (9)

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38000, France

Location

L'Hôpital Privé du Confluent

Nantes, 44000, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

Location

Georgian Israeli Research Medical Centre Helsicore

Tbilisi, Georgia

Location

Vilniaus universiteto ligoninė Santaros klinikos

Vilnius, 08410, Lithuania

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

• Alfonso F, Shaburishvili T, Farah B, Gogorishvili I, Monsegu J, Baranauskas A, Bressollette E, Shaburishvili G, Cuesta J, Rivero F, Moreno R, Sabate M. First-in-man study of a novel everolimus-coated balloon for the treatment of coronary in-stent restenosis. Coron Artery Dis. 2025 Mar 1;36(2):91-98. doi: 10.1097/MCA.0000000000001459. Epub 2024 Nov 27.

  PMID: 39601687 DERIVED

Results Point of Contact

• Title: Krista Stiefel, Principal Clinical Scientist
• Organization: Abbott

krista.stiefel@abbott.com

+12246689359

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 16, 2023
• Study Start: October 20, 2021
• Primary Completion: September 19, 2022
• Study Completion: May 8, 2025
• Last Updated: September 19, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-09

Locations

ES (3); FR (3); LI (1); GE (2)