Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)

Medtronic

Status and phase: Completed; Phase 3

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

Treatments: Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02452736

CV-Resolute Integrity China

Details and patient eligibility

About

The purpose of this study is to conduct a prospective, multi-center, single arm, non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Full description

This is a Pre-market, Prospective, Multi-center, Single arm, Non-randomized Study.

The objective of this study is to:

• To assess the deliverability of the Resolute Integrity Stent for suitable patients according to Indication for Use with a reference vessel diameter (RVD) of 2.25 mm to 4.0 mm in 200 evaluable patients
• To assess the in-hospital Major Adverse Cardiac Event (MACE) rate
• To collect data on resource utilization in the catheterization lab. At least 200 evaluable patients from about 15 study centers in China who meet the eligibility criteria and sign the informed consent form will participate in this study.

The expected time of participation in the study for each subject is from informed consent sign-off up to hospital discharge.

An angiographic core laboratory and a Clinical Events Committee (CEC) will be utilized. Adjudication of pre-specified clinical endpoint events will be done by an independent Clinical Events Committee. An angiographic core laboratory will review all baseline, procedural, and clinical event angiograms for all patients.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is older than or equal to 18 years
2. The patient 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 stent
3. The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
4. Intention to implant at least one Resolute Integrity stent during percutaneous coronary intervention (PCI)
5. Patient agrees to have all study procedures performed, and is willing to comply with all protocol-required evaluations

Exclusion criteria

1. Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
2. History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
3. A woman who is pregnant, planning to be pregnant or lactating
4. Currently participating in another trial
5. Situation that will prevent dual anti-platelet therapy to be maintained throughout the peri-surgical period
6. Previous enrollment in the China Resolute Integrity Study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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205 participants in 1 patient group

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Experimental group

Description:

This is a Single arm, Non-randomized Study. All patients meet the eligibility criteria and sign the informed consent form will participate in this study.

Treatment:

Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System