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Trial record 140 of 5763 for:    Arteriosclerosis

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)

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ClinicalTrials.gov Identifier: NCT02452736
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHINA RESOLUTE INTEGRITY STUDY 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 --A Prospective, Multi-center, Single Arm, Non-randomized Study
Study Start Date : May 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
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.
Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System



Primary Outcome Measures :
  1. Device Specific Procedural Success [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days. ]
    Defined as device success (the attainment of less than 50% residual stenosis of the target lesion using only the study device) and no in-hospital MACE (composite of death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization).


Secondary Outcome Measures :
  1. Delivery Success [ Time Frame: Participants will be followed at the end of index procedure, an expected average of 3 days. ]
    Defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.

  2. Device Success [ Time Frame: Participants will be followed at the end of index procedure, an expected average of 3 days. ]
    defined as the attainment of less than 50% residual stenosis of the target lesion using only the Resolute Integrity stent.

  3. Lesion Success [ Time Frame: Participants will be followed at the end of index procedure, an expected average of 3 days. ]
    Defined as the attainment of less than 50% residual stenosis by any percutaneous method.

  4. Procedure Success [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days. ]
    Defined as the attainment of less than 50% residual stenosis by any percutaneous method and no in-hospital MACE.

  5. In-hospital Major Adverse Cardiac Events (MACE) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days. ]
    Defined as the composite of as in-hospital death, myocardial infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat target lesion revascularization (TLR; clinically driven/clinically indicated) by percutaneous or surgical method.

  6. In-hospital Target Lesion Failure (TLF) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days. ]
    Defined as the composite of cardiac death, myocardial infarction (not clearly attributable to a non-target vessel) or target lesion revascularization (TLR; clinically indicated).

  7. Procedure time (min) [ Time Frame: Participants will be followed at the end of index procedure, an expected average of 3 days. ]
    Resource Utilization

  8. Contrast volume used (ml) [ Time Frame: Participants will be followed at the end of index procedure, an expected average of 3 days. ]
    Resource Utilization

  9. Usage of guiding catheters [ Time Frame: Participants will be followed at the end of index procedure, an expected average of 3 days. ]
    Resource Utilization

  10. Usage of guide wires [ Time Frame: Participants will be followed at the end of index procedure, an expected average of 3 days. ]
    Resource Utilization

  11. Usage of angioplasty balloons [ Time Frame: Participants will be followed at the end of index procedure, an expected average of 3 days. ]
    Resource Utilization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452736


Locations
China, Hubei
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
China, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Sponsors and Collaborators
Medtronic Vascular

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02452736     History of Changes
Other Study ID Numbers: CV-Resolute Integrity China
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Arteriosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs