Prostent: ProStent Coronary Drug-Eluting Stent

• Sponsor: CCRF Consulting Co., Ltd. (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00887211
• Collaborator: (none)
• Enrollment: 290
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 17.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Device: stent; Device: stent	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Trial Program of a Medical Instrument Product
• Study Start Date: Oct 1, 2008
• Anticipated Primary Completion Date: Feb 1, 2010
• Anticipated Study Completion Date: Mar 1, 2010

Arms and Interventions

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
Active Comparator: Firebird implant Firebird drug-eluting stents	Device: stent; Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.; Other Names: Firebird drug-eluting stents

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing		China	100037

Sponsors and Collaborators

• CCRF Consulting Co., Ltd.

Investigators

• Principal Investigator: Runlin Gao, Fuwai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00887211
• Other Study ID Numbers: Prostent
• First Posted: Apr 23, 2009
• Last Update Posted: Apr 30, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: stent; coronary artery disease
• Additional relevant MeSH terms: Coronary Disease; Sirolimus

Study Results

No Results Posted as of Apr 30, 2009