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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
PCI of in-stent restenosis
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
The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
Time frame: 6 months post-index procedure
The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL)
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.
Time frame: 180 days post-procedure
Composite Rate of Target Lesion Failure (TLF)
TLF is defined as composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
Time frame: 30 days post-procedure, 12 months, 24 months and 36 months
Composite Rate of Target Vessel Failure (TVF)
Target vessel failure (TVF) is defined as composite rate of cardiovascular death, target vessel myocardial infarction, and target vessel revascularization (TVR).
Time frame: 30 days post-procedure, 180 days, 12 months, 24 months and 36 months
Clinically Driven Target Lesion Revascularization (TLR)
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.
Time frame: 12 months, 24 months and 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Georgian Israeli Research Medical Centre Helsicore
Tbilisi, Georgia
Vilniaus universiteto ligoninė Santaros klinikos
Vilnius, Lithuania
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Clinically-driven Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Time frame: 180 days, 12 months, 24 months and 36 months
Rate of Vascular Access Site Complications
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.
Time frame: 12 months
Lesion Success:
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.
Time frame: 12 months
Technical Success
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.
Time frame: 12 months
Clinical Success (Per Subject)
Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure.
Time frame: 12 months
Procedural Success
Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure.
Time frame: 12 months