To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent

CGBio

Status: Unknown

Conditions: Ischemic Heart Disease; NSTEMI - Non-ST Segment Elevation MI; Unstable Angina; Stable Coronary Artery Disease; Stable Angina

Treatments: Device: CGBio stent; Device: Biomatrix flex

Study type: Interventional

Funder types: Industry

Identifiers

NCT03089450

CG-DE-225-008

Details and patient eligibility

About

to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)

Full description

A Multicenter, subject-blinded, randomized study to evaluate safety and efficacy of CGBIO stent compared to Biomatrix Flex stent in patients undergoing drug-eluting stent procedure after coronary angiography

Enrollment: 112 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least one lesion with a diameter stenosis >50%
• suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;
• Gr 1 ≤TIMI flow

Exclusion criteria

• ST-segment elevation MI
• Bifurcation lesion
• Chronic total occulusion
• Restenosis lesion
• Graft vessel lesion
• Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year
• Cardiogenic shock or hemodynamic compromise
• Existing impairment in liver and kidney.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

CGBIO stent (DES)

Experimental group

Description:

The Co-Cr biodegradable polymer DES Sirolimus DRUG Ascorbic Acid(Vitamin C)

Treatment:

Device: CGBio stent

Biomatrix flex(DES)

Active Comparator group

Description:

The abluminal biodegradable polymer DES BA9™ (BIOLIMUS A9™) DRUG

Treatment:

Device: Biomatrix flex