Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease

NCT ID: NCT01418794

Last Updated: 2011-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary artery disease.

Detailed Description

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Conditions

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Acute Coronary Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low dose rapamycin group

Concentration of rapamycin was 1.5%

Group Type ACTIVE_COMPARATOR

Low dose rapamycin stent

Intervention Type DEVICE

Concentration of rapamycin is 1.5%

High dose rapamycin group

Concentration of rapamycin is 2.5%

Group Type EXPERIMENTAL

High dose rapamycin stent

Intervention Type DEVICE

Concentration of rapamycin is 2.5%

Interventions

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High dose rapamycin stent

Concentration of rapamycin is 2.5%

Intervention Type DEVICE

Low dose rapamycin stent

Concentration of rapamycin is 1.5%

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age from 18-85 years old, male or nonpregnant women
* asymptomatic ischemia, stable or unstable angina, old myocardial infarction patients
* at least one target lesion length ≥ 20 mm (Visual method)
* Target lesion diameter 2.5mm-4.0 mm (Visual method)
* Target lesion diameter stenosis ≥ 70%
* Patients who has indications for coronary artery bypass graft (CABG) surgery
* Patients who is voluntary, understand the purpose of the study, willing to accept angiography and clinical follow-up

Exclusion Criteria

* Acute myocardial infarction for less than 1 week
* Bridge vascular disease
* In-stent restenosis lesions
* Patient with bleeding tendency, history of active peptic ulcer, History of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half year, contraindications to anticoagulant therapy and antiplatelet
* Allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast agent, rapamycin and metal
* Life expectancy is less than 12 months
* Patient who has participated in other clinical trials but does not meet the deadline of the primary endpoint
* Poor patient compliance
* Heart transplant recipient
* Patient who had other stent implanted within 1 year
* Patient who has multi-vessel disease(Long lesions) and has already received other stent implantation
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenyang Northern Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shenyang Northern Hospital

Principal Investigators

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Ya-Ling Han, MD

Role: PRINCIPAL_INVESTIGATOR

Shenyang Northern Hospital

Locations

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The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Shenyang Northern Hospital

Shenyang, Liaoning, China

Site Status RECRUITING

Armed Police Force Medical College Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ya-Ling Han, MD

Role: CONTACT

+86-24-23922184

Yi Li, MD

Role: CONTACT

+86-24-23991876

Facility Contacts

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Bo Yu, MD

Role: primary

+86-451-86605346

Chuan-Yu Gao, MD

Role: primary

+86-371-65580011

Yi Li, MD

Role: primary

+86-24-28851168

Tie-Min Jiang, MD

Role: primary

+86-22-60578777

Other Identifiers

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SYNH-20101010

Identifier Type: -

Identifier Source: org_study_id

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