Status:
UNKNOWN
Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting st...
Detailed Description
Patients with true coronary bifurcation lesions (Medina \[1, 1, 1\] or \[0, 1, 1\]) will be enrolled and randomized to undergo two-stent double kissing crush technique with Orsiro or Xience. Pre-inter...
Eligibility Criteria
Inclusion
- Patients who are at least 20 years old and present with acute or chronic coronary syndrome.
- Patients who are suitable for PCI with DES implantation and provide written informed consent.
- Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique.
- Target vessels suitable for OCT examination.
- Women of childbearing potential must have a negative pregnancy (serum and/or urine) test within 7 days prior to index procedure in accordance with the institutional standard of care. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
Exclusion
- Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT)
- Estimated glomerular filtration rate \< 45 ml/min/1.73 m2
- Liver cirrhosis
- Life expectancy \< 1 year
- Planned surgery within 3 months
- Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months
- Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05200637
Start Date
February 1 2022
End Date
December 31 2024
Last Update
January 21 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan, 333