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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

November 17, 2010
October 17, 2013
December 2010
April 2013   (final data collection date for primary outcome measure)
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.
Cardiac death and myocardial infarction (not clearly attributable to a non-target vessel) [ Time Frame: 12m ] [ Designated as safety issue: Yes ]

Cardiac death: any death due to immediate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia). Unwitnessed death and death of unknown cause will be classified as cardiac death. This includes all procedure related deaths including those related to concomitant treatment.

Myocardial infarction (MI):

Including Q wave MI (QWMI), Medtronic Historical Definition of Non-Q Wave MI (NQWMI) and MI per extended historical definition.

Complete list of historical versions of study NCT01243749 on ClinicalTrials.gov Archive Site
  • 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
Overall stent thrombosis [ Time Frame: 12m ] [ Designated as safety issue: Yes ]
Defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
Not Provided
Not Provided
 
Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China
RESOLUTE China Registry: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Ischemic Heart Disease
  • Stenotic Coronary Lesion
  • Cardiovascular Diseases
  • Arteriosclerosis
  • Coronary Artery Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1800
July 2018
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01243749
IP124
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
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
Medtronic Vascular
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP