Evaluation of the Clinical Safety and Efficacy of the 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Subjects According to the Indication for Use.

Medtronic Vascular2 sites in 1 country40 target enrollmentApril 17, 2017

ConditionsIschemic Heart Disease Stenotic Coronary Lesion Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ischemic Heart Disease
Sponsor: Medtronic Vascular
Enrollment: 40
Locations: 2
Primary Endpoint: Late lumen loss, in stent
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 17, 2017

End Date

April 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Vascular

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Late lumen loss, in stent

Time Frame: 9 months (m)

Late lumen loss measured by quantitative coronary angiography (QCA)

Secondary Outcomes

Major Adverse Cardiac Events (MACE)(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
Death(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
Target Lesion Failure (TLF)(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
Myocardial infarction(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
Stent Thrombosis (ST)(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
All revascularizations(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
Target Vessel Failure (TVF)(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
Device Success(At the end of index procedure, an expected average of 3 days)
Lesion Success(At the end of index procedure, an expected average of 3 days)
Procedure Success(Duration of hospital stay, an expected average of 5 days)
In-stent and in-segment percent diameter stenosis (%DS)(9 months)
In-stent and in-segment binary restenosis rate(9 months)
In-stent and in-segment minimal luminal diameter (MLD)(9 months)
In-segment late luminal loss(9 months)