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ProStent Coronary Drug-Eluting Stent

NCT ID: NCT00887211

Last Updated: 2009-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 90, 180, 270 and 365 days. Especially, standard quantity coronary angiography (QCA) will be conducted at 270 days(±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.

Conditions

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Coronary Disease

Keywords

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stent coronary artery disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ProStent

implant ProStent drug-eluting stents

Group Type ACTIVE_COMPARATOR

stent

Intervention Type DEVICE

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

Firebird

implant Firebird drug-eluting stents

Group Type ACTIVE_COMPARATOR

stent

Intervention Type DEVICE

Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.

Interventions

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stent

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

Intervention Type DEVICE

stent

Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.

Intervention Type DEVICE

Other Intervention Names

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ProStent rapamycin-eluting stent system Firebird drug-eluting stents

Eligibility Criteria

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Inclusion Criteria

1. Age 18-75 years, men or unpregnant women;
2. Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
3. Total of lesion artery ≤2;
4. Lesion artery ≤30 mm in length, 2.5 to 4.0 mm in diameter (ocular estimate);
5. Narrow level of lesion artery ≥70% in diameter (ocular estimate);
6. Amount of same stents implanted in a lesion artery ≤2;
7. Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
8. 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

Exclusion Criteria

1. Patients with acute myocardial infarction in recent one month;
2. 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;
3. Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
4. In-stent restenosis lesions;
5. Patients with stent implantation in his/her coronary artery within recent one year;
6. Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)\< 40%( supersonic inspection or left ventricular radiography );
7. Kidney functional damage prior to implantation, serum creatinine level\>2.0mg/dl;
8. 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;
9. Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
10. Patients whose life expectancy less than 12 months;
11. Patients who are participating in other drugs or medical devices clinical trials;
12. Patients who can not comply with the clinical trial protocol;
13. Patients having a heart transplant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CCRF Consulting Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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CCRF

Principal Investigators

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Runlin Gao

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaohong He

Role: CONTACT

Phone: 86-10-84094918

Email: [email protected]

Facility Contacts

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Runlin Gao

Role: primary

Other Identifiers

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Prostent

Identifier Type: -

Identifier Source: org_study_id