NCT00887211

Brief Summary

A single blind, multi-center, randomized study is preformed to compare ProStent drug-eluting stents with Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of ProStent drug-eluting stent in treating coronary artery lesions.

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
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 30, 2009

Status Verified

April 1, 2009

Enrollment Period

1.3 years

First QC Date

April 21, 2009

Last Update Submit

April 29, 2009

Conditions

Coronary Disease

Keywords

stentcoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Late luminal loss(LLL) detected through quantity coronary angiography (QCA) at 270 days(±30days) follow-up

    270 days(±30days)

Study Arms (2)

ProStent

ACTIVE COMPARATOR

implant ProStent drug-eluting stents

Device: stent

Firebird

ACTIVE COMPARATOR

implant Firebird drug-eluting stents

Device: stent

Interventions

stentDEVICE

ProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd.

Also known as: ProStent rapamycin-eluting stent system
ProStent

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years, men or unpregnant women;
  • Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
  • Total of lesion artery ≤2;
  • Lesion artery ≤30 mm in length, 2.5 to 4.0 mm in diameter (ocular estimate);
  • Narrow level of lesion artery ≥70% in diameter (ocular estimate);
  • Amount of same stents implanted in a lesion artery ≤2;
  • Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
  • Patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept fellow-up

You may not qualify if:

  • Patients with acute myocardial infarction in recent one month;
  • Chronic total occlusion lesions(TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.5mm;
  • Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
  • In-stent restenosis lesions;
  • Patients with stent implantation in his/her coronary artery within recent one year;
  • Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)\< 40%( supersonic inspection or left ventricular radiography );
  • Kidney functional damage prior to implantation, serum creatinine level\>2.0mg/dl;
  • Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;
  • Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
  • Patients whose life expectancy less than 12 months;
  • Patients who are participating in other drugs or medical devices clinical trials;
  • Patients who can not comply with the clinical trial protocol;
  • Patients having a heart transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Runlin Gao

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohong He

CONTACT

86-10-84094918danielle_he@ccheart.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

October 1, 2008

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

April 30, 2009

Record last verified: 2009-04

Locations

CN(1)