Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jan 16, 2022

Keywords

ClinConnect Summary

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-intervention and post-stenting optical coherence tomography will be performed during the index procedure. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy. All subjects will receive coronary angiography and optical coherence tomography follow-up at 3 and 12 months.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who are at least 20 years old and present with acute or chronic coronary syndrome.
• • 2. Patients who are suitable for PCI with DES implantation and provide written informed consent.
• • 3. Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique.
• • 4. Target vessels suitable for OCT examination.
• • 5. 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 Criteria:
• • 1. Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT)
• • 2. Estimated glomerular filtration rate \< 45 ml/min/1.73 m2
• • 3. Liver cirrhosis
• • 4. Life expectancy \< 1 year
• • 5. Planned surgery within 3 months
• • 6. Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months
• • 7. Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction