China Resolute Integrity 34/38 mm Study

NCT ID: NCT03118531

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2023-04-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coronary Stent

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.

Interventions

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

The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Vascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lianglong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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MDT16003RES001

Identifier Type: -

Identifier Source: org_study_id

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