Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China (R-C Registry)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01243749
First received: November 17, 2010
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.


Condition
Ischemic Heart Disease
Stenotic Coronary Lesion
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: RESOLUTE China Registry: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Target lesion failure (TLF) [ Time Frame: 12m ] [ Designated as safety issue: Yes ]
    Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods at 1 year.


Secondary Outcome Measures:
  • Overall stent thrombosis [ Time Frame: 12m ] [ Designated as safety issue: Yes ]
    Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.

  • Device success, Lesion success, Procedural success [ Time Frame: At the end of the index procedure or during hospital stay ] [ Designated as safety issue: Yes ]
  • TLF [ Time Frame: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
    Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year

  • All deaths (cardiac, vascular and non-cardiovascular) [ Time Frame: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis rate [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
    defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)

  • Myocardial infarction [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
    Q wave and non-Q wave MI

  • Revascularization [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: No ]
    target lesion and target vessel revascularization (TLR and TVR)

  • Significant bleeding complications and stroke [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
    hemorrhagic in nature

  • Target vessel failure (TVF) [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
    a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization

  • Major adverse cardiac events (MACE) [ Time Frame: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year ] [ Designated as safety issue: Yes ]
    a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods


Enrollment: 1800
Study Start Date: December 2010
Estimated Study Completion Date: July 2018
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.

Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.

1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System.

All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.

Criteria

Inclusion Criteria:

Patient must meet all of the following criteria to be eligible for treatment in the trial:

  1. Age ≥ 18 years or minimum age as required by local regulations
  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 stent and the Declaration of Helsinki
  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 electively implant at least one Resolute stent
  5. The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria:

Patients will be excluded from the trial if any of the following criteria are met:

  1. Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
  2. Women with known pregnancy or who are lactating
  3. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  4. Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
  5. Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
  6. Previous enrollment in the Resolute China Registry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243749

Locations
China
Beijing Fumwai Hospital
Beijing, China, 100000
Peiking University People's Hospital
Beijing, China, 100044
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Guangdong Provincial People's Hospital
Guangdong, China, 510000
Nanjing First Hospital
Nanjing, China, 210006
Wuhan Asia Heart Hospital
Wuhan, China, 430022
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Shubin Qiao, MD Beijing Fuwai Hospital
Principal Investigator: Jiyan Chen, MD Guangdong Provincial People's Hospital
Principal Investigator: Lianglong Chen, MD Fujian Medical University
Principal Investigator: Shaoliang Chen, MD Nanjing First Hospital
Principal Investigator: Weimin Wang, MD Peiking University People's Hospital
Principal Investigator: Guoying Zhu, MD Wuhan Asia Heart Hospital
  More Information

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01243749     History of Changes
Other Study ID Numbers: IP124
Study First Received: November 17, 2010
Last Updated: October 17, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Medtronic Vascular:
Target Vessel Revascularization (TVR)
Target Lesion Revascularization (TLR)
Myocardial Infarction (MI)
Target Vessel Failure (TVF)
Target Lesion Failure (TLF)
Stent Thrombosis
Restenotic Lesion
Percutaneous Coronary Intervention (PCI)
Real-world

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

ClinicalTrials.gov processed this record on April 17, 2014