Excel Drug-Eluting Stent Pilot Clinical Registry
Phase 4
Completed
- Conditions
- Coronary Stenosis
- Registration Number
- NCT00385905
- Lead Sponsor
- JW Medical Systems Ltd
- Brief Summary
The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.
- Detailed Description
30-day, 6-month, and 12-month clinical follow-up and 6 to 9-month IVUS or SCA follow-up to measure long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Patients who should fulfill with criteria of implanting Excel stents.
- Each patient enrolled is only allowed to implant Excel stents.
- Each patient are not allowed to be implanted more than 6 Excel stents.Also, 3 over-lapped stents are not allowed to be implanted in the same vessel(3-5mm overlapping needed; length of stents totally are not allowed to be over 80mm; fully post-dilated is essential for overlapping).
- Patients acknowlegement to the trial is essential.
Exclusion Criteria
- AMI withine 1 week.
- Patients who do not suitable to Excel stenting.(For example, non-tolerant to anti-platelet drug or cardiac/non-cardiac surgery undergoing recently.)
- Patients who have multiple branch lesions can not apply single Excel stenting.
- Patients who refuse to sign the Trial Acknowledgement.
- Patients with intra-stent restenosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 12-month MACE
- Secondary Outcome Measures
Name Time Method 30-day or 6-month MACE 6 to 9-month restenosis rate by SCA follow-up
Trial Locations
- Locations (1)
Shenyang Nothern Hospital
🇨🇳Shenyang, Liaoning, China