NCT01418794

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
606

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

August 17, 2011

Status Verified

October 1, 2010

Enrollment Period

1.1 years

First QC Date

August 16, 2011

Last Update Submit

August 16, 2011

Conditions

Acute Coronary Syndromes

Keywords

Acute Coronary SyndromesDrug eluting stentDiffused lesion

Outcome Measures

Primary Outcomes (1)

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

    270 days

Secondary Outcomes (4)

  • Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment

    270 days

  • Composite end point of major adverse cardiac events(MACE)

    30 days, 6 months, 9 months, 1 year

  • Stent thrombosis events after PCI for 24 hours, 30 days and 1 year

    24 hours, 30 days and 1 year

  • Success rate of stent implantation

    1 year

Study Arms (2)

Low dose rapamycin group

ACTIVE COMPARATOR

Concentration of rapamycin was 1.5%

Device: Low dose rapamycin stent

High dose rapamycin group

EXPERIMENTAL

Concentration of rapamycin is 2.5%

Device: High dose rapamycin stent

Interventions

High dose rapamycin stentDEVICE

Concentration of rapamycin is 2.5%

High dose rapamycin group
Low dose rapamycin stentDEVICE

Concentration of rapamycin is 1.5%

Low dose rapamycin group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Shenyang Northern Hospital

Shenyang, Liaoning, 110016, China

RECRUITING

Armed Police Force Medical College Hospital

Tianjin, Tianjin Municipality, 300162, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ya-Ling Han, MD

    Shenyang Northern Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Ling Han, MD

CONTACT

+86-24-23922184hanyaling.nh@gmail.com

Yi Li, MD

CONTACT

+86-24-23991876doctorliyi@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 17, 2011

Study Start

October 1, 2010

Primary Completion

November 1, 2011

Last Updated

August 17, 2011

Record last verified: 2010-10

Locations

CN(4)