CVT-ISR First in Human Trial for Coronary In-Stent Restenosis
- Conditions
- In-stent Restenosis
- Interventions
- Device: Drug Eluting Balloon
- Registration Number
- NCT05731700
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 51
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug eluting balloon Drug Eluting Balloon Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
- Primary Outcome Measures
Name Time Method The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate 6 months post-index procedure Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL) 180 days post-procedure 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.
- Secondary Outcome Measures
Name Time Method Composite Rate of Target Lesion Failure (TLF) 30 days post-procedure and 12 months TLF is defined as composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
Composite Rate of Target Vessel Failure (TVF) 30 days post-procedure, 180 days and 12 months Target vessel failure (TVF) is defined as composite rate of cardiovascular death, target vessel myocardial infarction, and clinically-driven target vessel revascularization (TVR).
Clinically Driven Target Lesion Revascularization (TLR) 12 months TLR is defined as any repeat PCI of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Clinically-driven Target Vessel Revascularization (TVR) 180 days and 12 months TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Rate of Vascular Access Site Complications 12 months The rate of vascular access site complications is defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair, transfusion or a prolonged hospital stay or requiring a new hospital admittance.
Lesion Success: 12 months Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of \<30% (by QCA), using any device after wire passage through the lesion.
Technical Success 12 months Technical success, defined as achievement of a final in-lesion residual diameter stenosis of \<30% (by QCA), using the CVT Everolimus coated PTCA Catheter without a device malfunction after wire passage through the lesion.
Clinical Success (Per Subject) 12 months Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure.
Procedural Success 12 months Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure.
Trial Locations
- Locations (9)
Groupe Hospitalier Mutualiste de Grenoble
🇫🇷Grenoble, France
L'Hôpital Privé du Confluent
🇫🇷Nantes, France
Clinique Pasteur
🇫🇷Toulouse, France
Tbilisi Heart and Vascular Clinic
🇬🇪Tbilisi, Georgia
Vilniaus universiteto ligoninė Santaros klinikos
🇱🇹Vilnius, Lithuania
Georgian Israeli Research Medical Centre Helsicore
🇬🇪Tbilisi, Georgia
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain