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Efficacy and Safety of RESOLUTE Zotarolimus-Eluting Stent in Treatment of Chinese Diabetic Coronary Lesions (RESOLUTE-DM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747356
First Posted: December 11, 2012
Last Update Posted: November 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
  Purpose
Resolute zotarolimus-eluting stent (ZES) system (Medtronic, USA) has been world-wildly used in treating patients with coronary artery disease (CAD). The State Food and Drug Administration of China has approved qualification of RESOLUTE zotarolimus-eluting stent system in 2010. It has been reported that RESOLUTE stent may be more suitable for DM patients and FDA has approved diabetic coronary lesion as a indication for using Resolute stent. Here the investigators set out a multicenter, non-inferiority study: the efficacy and safety of RESOLUTE zotarolimus-eluting stents in treatment of Chinese diabetes (RESOLUTE-DIABETES CHINA) in purpose of identifying the efficacy and safety in Asia CAD correlated with diabetic population.

Condition Intervention
Coronary Artery Disease Diabetes Device: Resolute stent treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Resolute Coronary Stent System in Treating Diabetic Coronary Lesions

Further study details as provided by Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 12-month TVF occurrence [ Time Frame: 12-month ]

    TVF definition

    1. Cardiac death (CD)
    2. Occurrence of myocardial infarction (Q wave or non-Q wave) in heart wall related to previously RESOLUTE stent treated coronary artery (LAD correspond to anterior wall, LCX correspond to lateral wall, RCA correspond to inferior wall).
    3. Clinical symptom related target vessel revascularization including PCI or coronary artery bypass grafting.


Secondary Outcome Measures:
  • Patient related adverse events [ Time Frame: 12-month ]
    1. Patient related adverse events including all-cause death, stroke, bleeding and revascularization. Revascularization includes all clinical symptom related or non-clinical symptom related PCI or coronary artery by-pass grafting in previously RESOLUTE treated lesion/vessel or untreated lesion/vessel.
    2. Stent thrombosis according to ARC definition.


Enrollment: 1000
Study Start Date: February 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resolute stent treatment group

All patients will receive Resolute stent implantation to cure severe coronary atherosclerotic lesions.

RESOLUTE stent system specification (eluted zotarolimus 1.6μg/mm2):

After stent implantation, each patient will be followed up at time point of 30-day, 6-month and 12-month.

Follow-up window:

Duration of hospital stay Follow-up 1: 30days after procedure (±7 days) Follow-up 2: 6-month after procedure (±30 days) Follow-up 3: 12-month after procedure (±30 days)

Device: Resolute stent treatment
A well known coronary stent system that is produced by Medtronic Company and is also recommended by FDA for treating diabetic coronary lesion.
Other Name: Resolute Zotarolimus-eluting coronary stent system

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

Age ≥ 18. Diagnosed as type 2 diabetes before PCI procedure (Supervised by center study institution) RESOLUTE zotarolimus eluting stents are the proper selection according to researcher's opinion.

Patient or guardian has signed the informed consent.

Exclusion Criteria:

Women during gestation or lactation. Bypass vessel disease after coronary artery bypass grafting (CABG). Any other brand of coronary artery stent has been implanted. Patients with impaired fast glucose level (6.0mmol/L-7.0mmol/L) or impaired carbohydrate tolerance (OGTT 2h glucose level within 7.8mmol/L-11.1mmol/L).

Any non-balloon vascularization or intra-vessel radiation has been used. Expected life bellow 12 months. Allergy to aspirin, clopidogrel, heparin, stainless steel, contrast medium or zotarolimus.

Recently attend any other medication research or medical instrument research that possibly interfere RESOLUTE diabetes study.

Researcher declines the property of RESOLUTE zotarolimus eluting stent implantation.

Patients who cannot agree with the study protocol or cannot understand the peculiarity, circumscription and possible consequence so that the informed consent, clinical follow-up and the research process cannot be conducted.

  Contacts and Locations
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): NCT01747356


Locations
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Director: Weifeng Shen, MD.PhD. Rui Jin hospital, Shanghai Jiao Tong University school of medcine
Principal Investigator: Ruiyan Zhang, MD. Rui Jin hospital, Shanghai Jiao Tong University school of medcine