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

Primary Purpose

Acute Coronary Syndromes

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
High dose rapamycin stent
Low dose rapamycin stent
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring Acute Coronary Syndromes, Drug eluting stent, Diffused lesion

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The 2nd Affiliated Hospital of Harbin Medical UniversityRecruiting
  • Henan Provincial People's HospitalRecruiting
  • Shenyang Northern HospitalRecruiting
  • Armed Police Force Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low dose rapamycin group

High dose rapamycin group

Arm Description

Concentration of rapamycin was 1.5%

Concentration of rapamycin is 2.5%

Outcomes

Primary Outcome Measures

270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)

Secondary Outcome Measures

Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment
Composite end point of major adverse cardiac events(MACE)
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
according to ARC definition
Success rate of stent implantation

Full Information

First Posted
August 16, 2011
Last Updated
August 16, 2011
Sponsor
Shenyang Northern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01418794
Brief Title
Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
Acute Coronary Syndromes, Drug eluting stent, Diffused lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
606 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose rapamycin group
Arm Type
Active Comparator
Arm Description
Concentration of rapamycin was 1.5%
Arm Title
High dose rapamycin group
Arm Type
Experimental
Arm Description
Concentration of rapamycin is 2.5%
Intervention Type
Device
Intervention Name(s)
High dose rapamycin stent
Intervention Description
Concentration of rapamycin is 2.5%
Intervention Type
Device
Intervention Name(s)
Low dose rapamycin stent
Intervention Description
Concentration of rapamycin is 1.5%
Primary Outcome Measure Information:
Title
270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)
Time Frame
270 days
Secondary Outcome Measure Information:
Title
Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment
Time Frame
270 days
Title
Composite end point of major adverse cardiac events(MACE)
Description
Composite end point of cardiac death, all Q-wave and non-Q wave myocardial infarction, clinical-driven target lesion revascularisation
Time Frame
30 days, 6 months, 9 months, 1 year
Title
Stent thrombosis events after PCI for 24 hours, 30 days and 1 year
Description
according to ARC definition
Time Frame
24 hours, 30 days and 1 year
Title
Success rate of stent implantation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Ling Han, MD
Phone
+86-24-23922184
Email
hanyaling.nh@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Li, MD
Phone
+86-24-23991876
Email
doctorliyi@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Ling Han, MD
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 2nd Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Yu, MD
Phone
+86-451-86605346
Email
yubodr@163.com
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuan-Yu Gao, MD
Phone
+86-371-65580011
Email
Gaocy2000@yahoo.com.cn
Facility Name
Shenyang Northern Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Li, MD
Phone
+86-24-28851168
Email
doctorliyi@126.com
Facility Name
Armed Police Force Medical College Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300162
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tie-Min Jiang, MD
Phone
+86-22-60578777
Email
wjyxyfy@126.com

12. IPD Sharing Statement

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

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