China Resolute Integrity 34/38 mm Study

Medtronic

Status: Completed

Conditions: Coronary Artery Disease; Ischemic Heart Disease; Cardiovascular Diseases; Arteriosclerosis; Stenotic Coronary Lesion

Treatments: Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03118531

MDT16003RES001

Details and patient eligibility

About

To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity 34/38 mm stent
• The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent

Key Exclusion Criteria:

• STEMI within 24 hours
• Left main disease
• Bifurcation disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Coronary Stent

Experimental group

Description:

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm)

Treatment:

Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)