China Endeavor Registry: A Registry With The Endeavor Zotarolimus Eluting Coronary Stent in China

NCT00793312 | Completed

• 1 other identifier: version 3.0 - 12 Nov 2008
• Study Type: observational
• Target: 2,210
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to document the acute and mid-term safety and overall clinical performance of the Endeavor(TM) Zotarolimus Eluting Coronary stent system in a "real world" Chinese patient population requiring stent implantation. To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• MACE

  12 Months

Eligibility Criteria

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

Study Population

Patients with an indication for coronary stent implantation according to the 'Instructions for Use' of the Endeavor™ Zotarolimus Eluting Coronary Stent System, or at investigators' discretion. All consecutive patients who receive one or more Endeavor™ stents in one or more target lesions should be included.

You may qualify if:

• Patient is \> 18 years of age (or minimum age as required by local regulations).
• The patient has consented to participate by signing the "Patient Informed Consent Form" and/or has authorized the collection and release of his medical information by signing the "Patient Data Release Consent Form".
• Patient is suitable for implantation of one or more Endeavor™ Zotaroliums Eluting Coronary Stent System in one or more native artery target lesions.
• Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor™ Zotarolimus Eluting Coronary Stent System.
• The patient is willing and able to cooperate with registry procedures and required follow up

You may not qualify if:

• Women with known pregnancy or who are lactating.
• Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as zotaroliums, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
• Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
• Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
• Current medical condition with a life expectancy of less than 12 months.
• The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this Registry once.
• Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.

Sponsors & Collaborators

• Medtronic Vascular: lead
• Medtronic Cardiovascular Asia Pacific: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jiyan Chen, Professor

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Yaling Han, Professor

  Shenyang North Hospital

  PRINCIPAL INVESTIGATOR

• Yong Huo, Professor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Weimin Wang, Professor

  Beijing People's Hospital

  PRINCIPAL INVESTIGATOR

• Bo Xu, Director

  Fu Wai Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: October 17, 2012

Record last verified: 2012-10