CompletedNot Applicable

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

France, Georgia51 participantsStarted 2021-10-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.
✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 6 months post-index procedure

The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL)

Timeframe: 180 days post-procedure

Trial details

NCT IDNCT05731700

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-19

Results submitted2024-07-30

View on ClinicalTrials.gov More In-stent Restenosis trials