BVS Implantation in Patients With Variant Angina and MODe... | NCT02932553

Studies
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease

NCT02932553

Sponsor

Seung-Jung Park

Status

Withdrawn

Last Update Posted

Jan 2, 2024Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Angina Pectoris, Variant

Interventions

BVS+OMT

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

BVS was withdrawn from the market

Expanded Access Info

Start Date

Apr 19, 2017Actual

Primary Completion Date

Apr 19, 2017Actual

Completion Date

Apr 19, 2017Actual

First Submitted Date

Oct 12, 2016

First Submission Date that Met QC Criteria

Oct 12, 2016

First Posted Date

Oct 13, 2016Estimated

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

Dec 27, 2023

Last Update Posted Date

Jan 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seung-Jung Park, professor, Division of Cardiology, Department of Internal Medicine, Asan Medical CenterSponsor-Investigator

Lead Sponsor

Seung-Jung ParkOTHER

Collaborators

Name	Class
CardioVascular Research Foundation, Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.

Detailed Description

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BVS and OMT	Experimental	Optimal medical treatment + BVS implantation	Device: BVS+OMT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BVS+OMT	Device	bioresorbable vascular scaffold implantation plus optimal medical treatment	BVS and OMT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of all cause death, myocardial infarction, and angina-related hospitalization		2year

Secondary Outcomes

Measure	Description	Time Frame
Variant angina	by Ergonovine test	2year
All cause death		2year
Cardiac death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 19 and more
Vasospastic angina diagnosed by provocation test including ergonovine provocation coronary angiography or ergonovine echocardiogram
No-ischemia producing moderate coronary artery disease(stenosis>50%, FFR>0.8)

Exclusion Criteria:

Ischemic coronary lesion
Organic heart disease associated with myocardial ischemia or sudden cardiac death
History of percutaneous coronary intervention
Cerebrovascular diseases or peripheral disease
NYHA III and IV
Cardiac pacemaker or implantable defibrillator
Pregnancy or breast feeding
Life expectancy less than 2 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000788	Angina Pectoris, Variant

Ancestor Terms

ID	Term
D000789	Angina, Unstable
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided