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

NCT01747356 | Completed DMC

• 1 other identifier: RJH-20121111
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Diabetes

Outcome Measures

Primary Outcomes (1)

• 12-month TVF occurrence

  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.

  12-month

Secondary Outcomes (1)

• Patient related adverse events

  12-month

Study Arms (1)

Resolute stent treatment group

EXPERIMENTAL

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

Interventions

Resolute stent treatment DEVICE

A well known coronary stent system that is produced by Medtronic Company and is also recommended by FDA for treating diabetic coronary lesion.

Also known as: Resolute Zotarolimus-eluting coronary stent system

Resolute stent treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (3)

• Zhang RY, Zhang Q, Zhu JZ, Chen LL, Zhang CY, Zhou XC, Yuan Y, Zhong ZX, Li L, Qiu J, Wang W, Chen XM, Yang ZJ, Yan JC, Chen SL, Hou YQ, Wu YQ, Luo HM, Qiu JP, Zhu L, Wang Y, Fu GS, Wang JA, Ma KH, Yin YH, Zhang DF, Hu XS, Zhu GY, Shen WF; Safety and Efficacy Registry of Yinyi stent (SERY-I) Investigators. Safety and efficacy of polymer-free paclitaxel-eluting microporous stent in real-world practice: 1-year follow-up of the SERY-I registry. Chin Med J (Engl). 2011 Nov;124(21):3521-6. No abstract available.

  PMID: 22340171 RESULT

• Du R, Zhang RY, Zhang Q, Shi YH, Hu J, Yang ZK, Ding FH, Zhang JS, Shen WF. Assessment of the relation between IVUS measurements and clinical outcome in elderly patients after sirolimus-eluting stent implantation for de novo coronary lesions. Int J Cardiovasc Imaging. 2012 Oct;28(7):1653-62. doi: 10.1007/s10554-011-0007-z. Epub 2012 Jan 6.

  PMID: 22222382 RESULT

• Zhu Z, Zhu J, Du R, Zhang H, Ni J, Quan W, Hu J, Ding F, Yang Z, Zhang R. Efficacy of Zotarolimus-Eluting Stents in Treating Diabetic Coronary Lesions: An Optical Coherence Tomography Study. Adv Ther. 2020 Apr;37(4):1579-1590. doi: 10.1007/s12325-020-01273-6. Epub 2020 Mar 7.

  PMID: 32146703 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Weifeng Shen, MD.PhD.

  Rui Jin hospital, Shanghai Jiao Tong University school of medcine

  STUDY DIRECTOR

• Ruiyan Zhang, MD.

  Rui Jin hospital, Shanghai Jiao Tong University school of medcine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief doctor

Study Record Dates

• First Submitted: December 9, 2012
• First Posted: December 11, 2012
• Study Start: February 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

CN (1)