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

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.

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.