Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Shenyang Northern Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Shenyang Northern Hospital
Information provided by:
Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01418794
First received: August 16, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndromes |
Device: High dose rapamycin stent Device: Low dose rapamycin stent |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Shenyang Northern Hospital:
Primary Outcome Measures:
- 270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA) [ Time Frame: 270 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment [ Time Frame: 270 days ] [ Designated as safety issue: No ]
- Composite end point of major adverse cardiac events(MACE) [ Time Frame: 30 days, 6 months, 9 months, 1 year ] [ Designated as safety issue: Yes ]Composite end point of cardiac death, all Q-wave and non-Q wave myocardial infarction, clinical-driven target lesion revascularisation
- Stent thrombosis events after PCI for 24 hours, 30 days and 1 year [ Time Frame: 24 hours, 30 days and 1 year ] [ Designated as safety issue: Yes ]according to ARC definition
- Success rate of stent implantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 606 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Low dose rapamycin group
Concentration of rapamycin was 1.5%
|
Device: Low dose rapamycin stent
Concentration of rapamycin is 1.5%
|
|
Experimental: High dose rapamycin group
Concentration of rapamycin is 2.5%
|
Device: High dose rapamycin stent
Concentration of rapamycin is 2.5%
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418794
Contacts
| Contact: Ya-Ling Han, MD | +86-24-23922184 | hanyaling.nh@gmail.com |
| Contact: Yi Li, MD | +86-24-23991876 | doctorliyi@126.com |
Locations
| China, Heilongjiang | |
| The 2nd Affiliated Hospital of Harbin Medical University | Recruiting |
| Harbin, Heilongjiang, China, 150081 | |
| Contact: Bo Yu, MD +86-451-86605346 yubodr@163.com | |
| China, Henan | |
| Henan Provincial People's Hospital | Recruiting |
| Zhengzhou, Henan, China, 450003 | |
| Contact: Chuan-Yu Gao, MD +86-371-65580011 Gaocy2000@yahoo.com.cn | |
| China, Liaoning | |
| Shenyang Northern Hospital | Recruiting |
| Shenyang, Liaoning, China, 110016 | |
| Contact: Yi Li, MD +86-24-28851168 doctorliyi@126.com | |
| China, Tianjin | |
| Armed Police Force Medical College Hospital | Recruiting |
| Tianjin, Tianjin, China, 300162 | |
| Contact: Tie-Min Jiang, MD +86-22-60578777 wjyxyfy@126.com | |
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
| Principal Investigator: | Ya-Ling Han, MD | Shenyang Northern Hospital |
More Information
No publications provided
| Responsible Party: | Yaling Han, M.D. PhD, Shenyang Northern Hospital |
| ClinicalTrials.gov Identifier: | NCT01418794 History of Changes |
| Other Study ID Numbers: | SYNH-20101010 |
| Study First Received: | August 16, 2011 |
| Last Updated: | August 16, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Shenyang Northern Hospital:
|
Acute Coronary Syndromes Drug eluting stent Diffused lesion |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 22, 2013