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ProStent Coronary Drug-Eluting Stent (Prostent)

Primary Purpose

Coronary Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

stent

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring stent, coronary artery disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ProStent

Firebird

Arm Description

implant ProStent drug-eluting stents

implant Firebird drug-eluting stents

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00887211

First Posted

April 21, 2009

Last Updated

April 29, 2009

Sponsor

CCRF Consulting Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00887211

Brief Title

ProStent Coronary Drug-Eluting Stent

Acronym

Prostent

Official Title

Clinical Trial Program of a Medical Instrument Product

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

February 2010 (Anticipated)

Study Completion Date

March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

CCRF Consulting Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease

Keywords

stent, coronary artery disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ProStent

Arm Type

Active Comparator

Arm Description

implant ProStent drug-eluting stents

Arm Title

Firebird

Arm Type

Active Comparator

Arm Description

implant Firebird drug-eluting stents

Intervention Type

Device

Intervention Name(s)

stent

Other Intervention Name(s)

ProStent rapamycin-eluting stent system

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

stent

Other Intervention Name(s)

Firebird drug-eluting stents

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

270 days(±30days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaohong He

Phone

86-10-84094918

Ext

821

danielle_he@ccheart.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Runlin Gao

Organizational Affiliation

Fuwai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Hospital

City

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Runlin Gao

gaorunlin@263.net

12. IPD Sharing Statement

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ProStent Coronary Drug-Eluting Stent

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