Status:
UNKNOWN
Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion
Lead Sponsor:
Yonsei University
Conditions:
Coronary Artery Disease
Stable Angina
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the pa...
Eligibility Criteria
Inclusion
- Single lesion in a Single vessel
- Reference vessel diameter 2.5 - 3.5 mm
- Lesion length ≤ 34 mm and ≤ 34 mm stent length
- Stable angina requiring revascularization, patients with unstable angina
- The patient has no difficulty to enforce the follow-up angiography
- Patient is ≥ 20 years old
Exclusion
- Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents
- Reference vessel diameter \< 2.5 mm or \> 4.0mm
- Contraindication to anti-platelet agents
- Treated with any DES within 3 months at other vessel
- Creatinine level ≥ 2.0 mg/dL or ESRD
- Severe hepatic dysfunction (3 times normal reference values)
- Patients with LVEF \< 30%
- Life expectancy 1 year
- Lesions with CTO or left main
- Target vessel of ST-elevation MI
- Lesions requiring overlapped stenting or more than 2 DES in each vessel
- Heavy calcified lesions (definite calcified lesions on angiogram)
- Far distal or tortuous lesions having difficulties in OCT evaluation or follow-up OCT
- Pregnant women or women with potential childbearing
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01869842
Start Date
December 1 2011
End Date
December 1 2016
Last Update
June 5 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Severance Hospital
Seoul, Seoul, South Korea, 120-752