Safety and Efficacy of the CRE8 Stent for the Treatment of De Novo Coronary Artery Lesions

NCT02360423 | Unknown Phase 3 DMC

• 1 other identifier: CRE8-China-RCT
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss (LLL)

  9months after the procedure

Secondary Outcomes (7)

• In-stent, proximal stent edge, distal stent edge and In-segment binary restenosis rate

  9months after the procedure

• In-segment late lumen loss (LLL)

  9months after the procedure

• Target lesion failure (TLF) rate

  1month, 6months, 9months, 12months and annually up to 5 years follow-up

• Number of participants with stent thrombosis per ARC definition

  1month, 6months, 9months, 12months and annually up to 5 years follow-up

• The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations

  1month, 6months, 9months, 12months and annually up to 5 years follow-up

Study Arms (2)

CRE8 group

EXPERIMENTAL

CRE8 sirolimus-eluting stent system

Device: CRE8 sirolimus-eluting stent

RESOLUTE group

ACTIVE COMPARATOR

RESOLUTE zotarolimus-eluting stent system

Device: RESOLUTE zotarolimus-eluting stent

Interventions

CRE8 sirolimus-eluting stent DEVICE

The CRE8 stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium alloy and is coated with i-carbofilm.The outer surface of the stent has dedicated grooves for containing the pharmaceutical formulation, which is composed of the drug sirolimus and a mixture of long chain fatty acids.

CRE8 group

RESOLUTE zotarolimus-eluting stent DEVICE

The RESOLUTE stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium tungsten alloy. It has been approved by CFDA in 2009 and commercially available in Chinese market

RESOLUTE group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤ 75 years, male or female without pregnancy;
• Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
• De novo lesions of native coronary arteries (lesions number ≤ 2);
• Target vessel diameter between 2.25 and 4.0 mm and target lesion length ≤ 27mm by visual estimation;
• Target lesion diameter stenosis ≥ 70% by visual estimation;
• Each target lesion is permitted to implant only one stent at most, except bailout stent;
• Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
• Patients with left ventricular ejection fraction ≥40%;
• Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consent.
• Age ≥18 years and ≤ 75 years, male or female without pregnancy;
• Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
• De novo lesions of native coronary arteries (lesions number ≤ 2);
• Target lesion diameter stenosis ≥ 70% by visual estimation;
• At least one target lesion with reference vessel diameter between 2.5mm and 4.0mm and requires 38mm stent exists;
• Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);

You may not qualify if:

• Patients with acute myocardial infarction (AMI) within one week;
• Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter \>2.5mm or graft lesions;
• Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
• In-stent restenosis;
• Thrombotic lesion;
• Patients who had received any other stent in the past one year;
• Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
• Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months;
• Patients who allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, zotarolimus, polymer, Co-Cr alloy, or with contraindication to aspirin or clopidogrel or ticagrelor;
• Patients with life expectancy less than 1year;
• Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
• Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol;
• Patients who had underwent heart transplant surgery.

Sponsors & Collaborators

• CID S.p.A.: lead

Study Sites (1)

Fuwai Hospital,National Center for Cardiovasular disease

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Shubin Qiao, MD

  Fu Wai Hospital, National Center for Cardiovasular disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shubin Qiao, MD

CONTACT

+86 13701237893; qli@ccrfmed.com;qsbfw@sina.com

Study Design

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

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 10, 2015
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: April 1, 2021
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

CN (1)