N/A
Completed N=51
CVT-ISR First in Human Trial for Coronary In-Stent Restenosis
Source: ClinicalTrials.gov NCT05731700 ↗Enrolled (actual)
51
Serious AEs
43.1%
Results posted
May 2025
Primary outcomePrimary: The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate — 4; 1; 0; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate |
4; 1; 0; 3 | — |
| PRIMARY The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL) |
0.40 | — |
| SECONDARY Composite Rate of Target Lesion Failure (TLF) |
1; 5; 5; 5 | — |
| SECONDARY Composite Rate of Target Vessel Failure (TVF) |
1; 7; 10; 10; 11 | — |
| SECONDARY Clinically Driven Target Lesion Revascularization (TLR) |
4; 4; 4 | — |
| SECONDARY Clinically-driven Target Vessel Revascularization (TVR) |
6; 7; 7; 7 | — |
| SECONDARY Rate of Vascular Access Site Complications |
0; 0; 0 | — |
| SECONDARY Lesion Success: |
50 | — |
| SECONDARY Technical Success |
47 | — |
| SECONDARY Clinical Success (Per Subject) |
47 | — |
| SECONDARY Procedural Success |
50 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Angiographic Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT05731700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.