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)

Last updated: April 6, 2016
Sponsor: Medtronic Vascular
Overall Status: Completed

Phase

3

Condition

Myocardial Ischemia

Coronary Artery Disease

Chest Pain

Treatment

N/A

Clinical Study ID

NCT02452736
CV-Resolute Integrity China
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 inaccordance with the applicable guidelines on percutaneous coronary interventions, theInstructions for Use of the Resolute Integrity stent

  3. The patient or legal representative has been informed of the nature of the trial andhas consented to participate and authorized the collection and release of his/hermedical information by signing a Patient Informed Consent Form

  4. Intention to implant at least one Resolute Integrity stent during percutaneouscoronary intervention (PCI)

  5. Patient agrees to have all study procedures performed, and is willing to comply withall protocol-required evaluations

Exclusion

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 adequatelypre-medicated

  2. History of an allergic reaction or significant sensitivity to drugs such aszotarolimus, 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 theperi-surgical period

  6. Previous enrollment in the China Resolute Integrity Study

Study Design

Total Participants: 205
Study Start date:
May 01, 2015
Estimated Completion Date:
December 31, 2015

Study 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.

Connect with a study center

  • Beijing Fuwai Hospital

    Beijing, Beijing 100037
    China

    Site Not Available

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Site Not Available

  • Xijing Hospital

    Xijing, Shanxi 710032
    China

    Site Not Available

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