Vascular Response of Orsiro vs. Xience Drug-Eluting Stent... | NCT05200637

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

NCT05200637

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Jan 21, 2022Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

Orsiro stent
Xience stent
Any drug-eluting stent

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jan 4, 2022

First Submission Date that Met QC Criteria

Jan 16, 2022

First Posted Date

Jan 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2022

Last Update Posted Date

Jan 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Orsiro stent	Device	Orsiro stent	Orsiro
Xience stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of stent strut coverage at bifurcation segments		3 months post-procedure

Secondary Outcomes

Measure	Description	Time Frame
Neointimal thickness (μm) at bifurcation segments		3 months post-procedure
Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments		3 months post-procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying-Chang Tung, MD	Contact	886-3-3281200	8162	n12374@cgmh.org.tw
Chi-Jen Chang, MD	Contact	886-3-3281200	8162	chijenformosa@gmail.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Linkou Chang Gung Memorial Hospital		Taoyuan		333	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided