ProStent Coronary Drug-Eluting Stent (Prostent)

April 29, 2009 updated by: CCRF Consulting Co., Ltd.

Clinical Trial Program of a Medical Instrument Product

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ProStent
implant ProStent drug-eluting stents
Device: stent
ProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd.
Other Names:
  • ProStent rapamycin-eluting stent system
Device: stent
Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.
Other Names:
  • Firebird drug-eluting stents
ACTIVE_COMPARATOR: Firebird
implant Firebird drug-eluting stents
Device: stent
ProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd.
Other Names:
  • ProStent rapamycin-eluting stent system
Device: stent
Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.
Other Names:
  • Firebird drug-eluting stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late luminal loss(LLL) detected through quantity coronary angiography (QCA) at 270 days(±30days) follow-up
Time Frame: 270 days(±30days)
270 days(±30days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CCRF Consulting Co., Ltd.

Investigators

  • Principal Investigator: Runlin Gao, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ANTICIPATED)

February 1, 2010

Study Completion (ANTICIPATED)

March 1, 2010

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (ESTIMATE)

April 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2009

Last Update Submitted That Met QC Criteria

April 29, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prostent

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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