Clinical trial NCT05200637: Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions
Official title: A Randomized, Parallel, Active Controlled Study to Evaluate the Vascular Response of Orsiro vs. Xience Drug Eluting Stent System in Subjects With Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug-eluting stents
Coronary bifurcation lesions
Double-kissing crush technique
Optical coherence tomography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with true coronary bifurcation lesions will be randomized to undergo two-stent DK-crush technique with Orsiro or Xience. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy.
Primary purpose: TREATMENT

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 stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. How the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.

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-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.

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

Primary outcomes:
measure: Percentage of stent strut coverage at bifurcation segments
timeFrame: 3 months post-procedure
Secondary outcomes:
measure: Neointimal thickness (μm) at bifurcation segments
timeFrame: 3 months post-procedure
measure: Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments
timeFrame: 3 months post-procedure
measure: Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments
timeFrame: 3 months post-procedure
measure: Percentage of acquired malapposed struts at bifurcation segments
timeFrame: 3 months post-procedure
measure: Percentage of stent strut coverage at bifurcation segments
timeFrame: 12 months post-procedure
measure: Neointimal thickness (μm) at bifurcation segments
timeFrame: 12 months post-procedure
measure: Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments
timeFrame: 12 months post-procedure
measure: Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments
timeFrame: 12 months post-procedure
measure: Percentage of acquired malapposed struts at bifurcation segments
timeFrame: 12 months post-procedure
measure: In-stent late-lumen loss by quantitative coronary analysis
timeFrame: 3 months post-procedure
measure: In-segment late lumen loss by quantitative coronary analysis
timeFrame: 3 months post-procedure
measure: Target Lesion Revascularization (TLR)
timeFrame: 3 months post-procedure
measure: Target Vessel Revascularization (TVR)
timeFrame: 3 months post-procedure
measure: Target Lesion Failure (TLF)
timeFrame: 3 months post-procedure
measure: Major Cardiac Adverse Events (MACE)
timeFrame: 3 months post-procedure
measure: Instent late-lumen loss by quantitative coronary analysis
timeFrame: 12 months post-procedure
measure: In-segment late lumen loss by quantitative coronary analysis
timeFrame: 12 months post-procedure
measure: Target Lesion Revascularization (TLR)
timeFrame: 12 months post-procedure
measure: Target Vessel Revascularization (TVR)
timeFrame: 12 months post-procedure
measure: Target Lesion Failure (TLF)
timeFrame: 12 months post-procedure
measure: Major Cardiac Adverse Events (MACE)
timeFrame: 12 months post-procedure
measure: Stent thrombosis
timeFrame: 1 months post-procedure
measure: Stent thrombosis
timeFrame: 3 months post-procedure
measure: Stent thrombosis
timeFrame: 12 months post-procedure
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
name: Ying-Chang Tung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
name: Chi-Jen Chang, MD
role: STUDY_CHAIR
affiliation: Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
name: Chia-Pin Lin, MD
role: STUDY_DIRECTOR
References: