NCT02360423

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

A Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of the CRE8 Sirolimus-Eluting Stent Versus the RESOLUTE Zotarolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: CID S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study consists of a randomized controlled cohort and a long stent observational cohort. The randomized controlled trial is a prospective, multi-center, non-inferior, randomized controlled trial. The control device (RESOLUTE zotarolimus-eluting stent) used in this trial was provided by Medtronic. RESOLUTE zotarolimus-eluting stent has been already approved by China Food and Drug Administration (CFDA) in 2009 and become commercially available in Chinese market. 400 patients enrolled in this trial will be randomly assigned to CRE8 group (n=200) and RESOLUTE group (n=200) in a 1:1 ratio. The long stent observational trial plans to enroll 30 consecutive patients. Patients in the observational cohort will receive the long CRE8 stent with length 38mm.All 430 patients will be required to receive clinical follow-up at 1 month, 6 months, 9 months, 12 months and annually up to 5 years after the procedure, and angiographic follow-up at 9 months after the procedure. The primary endpoint is in-stent LLL at 9 months after the procedure, and the secondary endpoints are device success rate, device-oriented cardiovascular composite endpoint, patient-oriented cardiovascular composite endpoint and stent thrombosis.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CRE8 sirolimus-eluting stent	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.
DEVICE	RESOLUTE zotarolimus-eluting stent	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

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-10-01
• Completion: 2021-04-01
• First posted: 2015-02-10
• Last updated: 2015-03-25

Locations

1 site across 1 country: China