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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Orsiro Drug Eluting Stent System

NCT01356888

Coronary Artery Disease

UNKNOWN NA

Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

NCT02508714

Coronary Artery Disease Angina Pectoris Unstable Angina Pectoris +3 more

UNKNOWN NA

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

NCT02389946

Coronary Artery Disease Atherosclerosis, Coronary Myocardial Ischemia +3 more

COMPLETED NA

ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography

NCT01594736

Coronary Heart Disease

COMPLETED PHASE4

Comparison of Biodegradable Stents: Orsiro and BioMatrix

NCT02084901

All-comer Percutaneous Coronary Intervention

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Orsiro

Two-stent DK-crush technique with Orsiro

Group Type ACTIVE_COMPARATOR

Orsiro stent

Intervention Type DEVICE

Orsiro stent

Xience

Two-stent DK-crush technique with Xience

Group Type ACTIVE_COMPARATOR

Xience stent

Intervention Type DEVICE

Xience stent

Single stent

Provisional one-stent strategy with any drug-eluting stent

Group Type OTHER

Any drug-eluting stent

Intervention Type DEVICE

Any drug-eluting stent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Orsiro stent

Intervention Type DEVICE

Xience stent

Intervention Type DEVICE

Any drug-eluting stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No