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ProStent Coronary Drug-Eluting Stent (Prostent)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by CCRF Consulting Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
CCRF Consulting Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00887211
First received: April 21, 2009
Last updated: April 29, 2009
Last verified: April 2009
History of Changes
  Purpose

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 Intervention
Coronary Disease
 Device: stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial Program of a Medical Instrument Product

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CCRF Consulting Co., Ltd.:

Primary Outcome Measures:
  • Late luminal loss(LLL) detected through quantity coronary angiography (QCA) at 270 days(±30days) follow-up [ Time Frame: 270 days(±30days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: October 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ProStent
implant ProStent drug-eluting stents
 Device: stent
ProStent rapamycin-eluting stent system manufactured by Tianjian Medical Technology (Suzhou) Co., Ltd.
Other Name: 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 Name: Firebird drug-eluting stents

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887211

Contacts
Contact: Xiaohong He 86-10-84094918 ext 821 danielle_he@ccheart.com.cn

Locations
China
Fuwai Hospital Recruiting
Beijing, China, 100037
Contact: Runlin Gao         gaorunlin@263.net    
Sponsors and Collaborators
CCRF Consulting Co., Ltd.
Investigators
Principal Investigator: Runlin Gao Fuwai Hospital
  More Information

No publications provided

Responsible Party: Xiaohong He, CCRF
ClinicalTrials.gov Identifier: NCT00887211     History of Changes
Other Study ID Numbers: Prostent
Study First Received: April 21, 2009
Last Updated: April 29, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by CCRF Consulting Co., Ltd.:
stent
coronary artery disease

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013