NCT01373658

Brief Summary

Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

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

May 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 15, 2011

Status Verified

March 1, 2010

Enrollment Period

1.4 years

First QC Date

April 1, 2011

Last Update Submit

June 13, 2011

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • late lumen loss

    Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up.

    12 months

Secondary Outcomes (1)

  • major adverse cardiac events

    12 months

Study Arms (1)

Yinyi stent

EXPERIMENTAL
Device: Yinyi stent

Interventions

Yinyi stentDEVICE

subjects with Yinyi stent implantation

Yinyi stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-80 years old
  • both gender
  • native coronary lesion
  • narrowing \> 70%
  • vessel size 2.5-4.0 in diameter

You may not qualify if:

  • without informed consent,
  • ST elevation myocardial infarction within 7 days,
  • patient with ≤ 70% coronary narrowing at target lesion,
  • left main lesion,
  • multivessel narrowing need more than 3 stent implantations,
  • by-pass graft,
  • abnormal liver function before randomization,
  • active hepatitis or muscular disease,
  • impaired renal function with serum creatinine level \> 3mg/dl,
  • impaired left ventricular function with LVEF \< 30%,
  • participate in other studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ruijin hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ruiyan Zhang, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruiyan Zhang, MD

CONTACT

862164370045zhangruiyan@263.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2011

First Posted

June 15, 2011

Study Start

May 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

June 15, 2011

Record last verified: 2010-03

Locations

CN(1)