Pilot Evaluation Of CORACTO® (THE PILOT-SECRET TRIAL)

NCT02076516 | Unknown Phase 3

• 1 other identifier: ALV-01
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the CORACTO® (Rapamycin®-Eluting coronary stent delivery system) for the treatment of up to two de novo lesions or restenotic post-PTCA (non-stented) lesions located in up to two epicardial native coronary arteries (maximum one lesion per vessel) suitable for treatment with stents from 2.5 to 4.0 mm in diameter \< than 15 mm suitable for treatment with a single CORACTO® stent in a population of 100 patients.

Conditions

Coronary Artery Disease

Keywords

Drug-eluting Stent,Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-stent late loss (LL) in patients implanted with a CORACTO® stent (per protocol analysis)

  at 6 months

Secondary Outcomes (1)

• Stent Thrombosis ( Definite and probable)

  at 30 days, 6 months and 12 months

Other Outcomes (5)

• Device-oriented Target Lesion Failure (TLF)

  at 30 days, 6 months and 12 months

• Patient Oriented Composite Endpoint Major Adverse Cardiac Events (MACE)

  at 30 days, 6 months and 12 months

• Total Revascularization Rate (clinically and non-clinically driven)

  at 30 days, 6months and 12 months

Study Arms (1)

Drug-eluting stent: CORACTO®

EXPERIMENTAL

Single arrm

Device: Drug-eluting stent: CORACTO®

Interventions

Drug-eluting stent: CORACTO® DEVICE

Drug-eluting stent: CORACTO®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years old.
• Patient is eligible for percutaneous coronary intervention (PCI) and acceptable candidate for coronary artery bypass grafting (CABG).
• Clinical evidence of ischemic heart disease and/or a positive functional study, stable angina pectoris (Canadian Cardiovascular Society Classification (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or silent ischemia.
• The target lesion(s) or target vessel(s) meet(s) all the following criteria:
• The target lesion is a single de novo lesion in a native coronary artery.
• The stenosis of target lesion(s) is ≥ 50% and \< 100% (by visual estimation).
• The target lesion length must be ≤ 15 mm. In case that a second stent should be required for successful treatment, it should be a CORACTO® stent.
• The target reference vessel diameter must be (by visual estimation) suitable for treatment with stents between 2.5 and 4.0 mm.
• Patient has been informed of the nature of the study, understands the study requirements, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
• The patient is willing and able to comply with all specified follow-up evaluations.

You may not qualify if:

• Most recent left ventricular ejection fraction (LVEF) of the patient is \< 25%.
• Known allergies to the following: aspirin, Clopidogrel bisulfate (Plavix®), Prasugrel (Effient®) or Ticlopidine (Ticlid®), heparin, Rapamycin, stainless steel, Poly Lactic - co- glycolic acid or contrast agent (that cannot be adequately premedicated).
• Platelet count is less than 100,000 cells/mm3 or more than 700,000 cells/mm3.
• White Blood Cell count is less than 3,500 cells/mm3.
• Evidence of an ST-segment elevation acute myocardial infarction (MI) or non-ST segment elevation MI with positive Troponin within 72 hours before the intended treatment.
• ANY previous PCI
• Planned staged procedures (patient with 2-vessel disease should be treated during the same procedure). Presence of any other significant lesion of \> 50% stenosis (by visual estimation) anywhere within the target vessel
• Significant lesions in any non-target vessel that will require interventional treatment within 30 days post-procedure
• Planned future interventional procedure in the target vessel .
• The target lesion(s) require(s) treatment with a device other than PTCA balloon prior to stent placement. (e.g. but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, thrombus aspiration etc.).
• Previous stenting anywhere within the target vessel(s)
• Target vessel has evidence of thrombus
• Excessive tortuosity (\> 60°) of the target vessel proximal to the target lesion (by visual estimation).
• The target lesion(s) has any of the following characteristics (by visual estimation):
• Ostial or bifurcation lesion (within 3mm from region of origin of target vessel, by visual estimation).

Sponsors & Collaborators

• Alvimedica: lead

Study Sites (5)

ZNA Middleheim

Antwerp, 2020, Belgium

RECRUITING

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

RECRUITING

Hospital Prive Jacques Cartier

Massy, 91300, France

RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Bezmialem University Hospital

Istanbul, 34093, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Javier Escaned, MD

CONTACT

escaned@secardiologia.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 3, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

BE (1); ES (1); TU (1); FR (2)