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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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In-stent Restenosis

Intervention / Treatment
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* Device: Drug Eluting Balloon


Participation Criteria
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Eligibility Criteria
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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. 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 < 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. 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. Restenosis is present in a stent previously deployed in the left main coronary artery. Subjects who are not candidates for coronary bypass surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from target lesion failure rate | Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR). | 6 months post-index procedure | 
| In-stent late lumen loss | In-stent late lumen loss (LLL) | 180 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR). | one year post-procedure | 
| Target vessel failure | Composite rate of cardiovascular death, target vessel myocardial infarction, and target vessel revascularization (TVR). | one year post-procedure |