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

NCT05200637 | Unknown DMC FDA Device

• 1 other identifier: 202101599A3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Drug-eluting stents; Coronary bifurcation lesions; Double-kissing crush technique; Optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Percentage of stent strut coverage at bifurcation segments

  3 months post-procedure

Secondary Outcomes (24)

• Neointimal thickness (μm) at bifurcation segments

  3 months post-procedure

• Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments

  3 months post-procedure

• Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments

  3 months post-procedure

• Percentage of acquired malapposed struts at bifurcation segments

  3 months post-procedure

• Percentage of stent strut coverage at bifurcation segments

  12 months post-procedure

Study Arms (3)

Orsiro

ACTIVE COMPARATOR

Two-stent DK-crush technique with Orsiro

Device: Orsiro stent

Xience

ACTIVE COMPARATOR

Two-stent DK-crush technique with Xience

Device: Xience stent

Single stent

OTHER

Provisional one-stent strategy with any drug-eluting stent

Device: Any drug-eluting stent

Interventions

Orsiro stent DEVICE

Orsiro stent

Orsiro

Xience stent DEVICE

Xience stent

Xience

Any drug-eluting stent DEVICE

Any drug-eluting stent

Single stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ying-Chang Tung, MD

  Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan

  PRINCIPAL INVESTIGATOR

• Chi-Jen Chang, MD

  Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan

  STUDY CHAIR

• Chia-Pin Lin, MD

  Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan

  STUDY DIRECTOR

Central Study Contacts

Ying-Chang Tung, MD

CONTACT

886-3-3281200; n12374@cgmh.org.tw

Chi-Jen Chang, MD

CONTACT

886-3-3281200; chijenformosa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 21, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)