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

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Orsiro stent; Device: Xience stent; Device: Any drug-eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT05200637

202101599A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Orsiro

Active Comparator group

Description:

Two-stent DK-crush technique with Orsiro

Treatment:

Device: Orsiro stent

Xience

Active Comparator group

Description:

Two-stent DK-crush technique with Xience

Treatment:

Device: Xience stent

Single stent

Other group

Description:

Provisional one-stent strategy with any drug-eluting stent

Treatment:

Device: Any drug-eluting stent