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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01747356
First received: December 9, 2012
Last updated: November 22, 2013
Last verified: November 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Resolute Coronary Stent System in Treating Diabetic Coronary Lesions

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 12-month TVF occurrence [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1000
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747356

Contacts
Contact: Ruiyan Zhang, MD 86-21-64370045 ext 665215 zhangruiyan@263.net
Contact: Zhengbin Zhu, MD 86-21-64370045 ext 665380 gemini198306@163.com

Locations
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Ruiyan Zhang, MD.    86-21-64370045 ext 665215    zhangruiyan@263.net   
Contact: Zhengbin Zhu, MD.    86-21-64370045 ext 665380    gemini198306@163.com   
Principal Investigator: Ruiyan Zhang, MD.         
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
  More Information

Additional Information:
Publications:
Responsible Party: Zhang Qi, MD, Chief doctor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01747356     History of Changes
Other Study ID Numbers: RJH-20121111
Study First Received: December 9, 2012
Last Updated: November 22, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014