Comparison of Biodegradable Stents: Orsiro and BioMatrix | NCT02084901

Studies
Comparison of Biodegradable Stents: Orsiro and BioMatrix

NCT02084901

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jul 27, 2016Estimated

Enrollment

12Actual

Phase

Phase 4

Conditions

All-comer
Percutaneous Coronary Intervention

Interventions

Drug-eluting biodegradable stent Orsiro implantation
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation

Countries

South Korea

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 9, 2014

First Submission Date that Met QC Criteria

Mar 11, 2014

First Posted Date

Mar 12, 2014Estimated

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

Jul 26, 2016

Last Update Posted Date

Jul 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.

The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.

Detailed Description

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orsiro Arm	Experimental		Device: Drug-eluting biodegradable stent Orsiro implantation
BioMatrix or BioMatrix Flex Arm	Active Comparator		Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug-eluting biodegradable stent Orsiro implantation	Device	Drug-eluting biodegradable stent Orsiro implantation	Orsiro Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neointimal coverage at 3 month after stent implantation	The percentage of stent uncoverage measured by optical coherence tomography	At 3 months after stent implantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥ 20 years old
Patients in the treatment of subjects with all-comer who are to undergo PCI

Exclusion Criteria:

Pregnant women or women with potential childbearing
Life expectancy < 1 year

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong		Seoul		120-752	South Korea