Plaque Stabilization and Restoration by Bioresorbable Vas... | NCT02319733

Studies
Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold

NCT02319733

Sponsor

Canisius-Wilhelmina Hospital

Status

Terminated

Last Update Posted

Feb 14, 2017Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Vulnerable Plaque

Interventions

Bioresorbable vascular scaffold

Countries

Netherlands

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient eligable subjects and new data on BVS

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Dec 14, 2014

First Submission Date that Met QC Criteria

Dec 14, 2014

First Posted Date

Dec 18, 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

Feb 11, 2017

Last Update Posted Date

Feb 14, 2017Actual

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 aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural vasomotion and increase vascular diameter.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bioresorbable vascular scaffold	Experimental	Implantation of Bioresorbable vascular scaffold in vulnerable plaques	Device: Bioresorbable vascular scaffold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bioresorbable vascular scaffold	Device	Implantation of Bioresorbable vascular scaffold in vulnerable plaques	Bioresorbable vascular scaffold

Measure	Description	Time Frame
change in plaque cumulative score of signs of vulnerability on CT		24 months
nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS		24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic patients between the age of 18 and 80 years
Morise Risk score of ≥9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)
Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification
FFR negative lesion at coronary angiogram
Vessel diameter ≥2.5 mm on visual estimate
GFR ≥ 45mL/min/1.73m².

Exclusion Criteria:

High calcium score on CT scan preventing adequate evaluation of the coronary lesion.
Lesions located in a coronary vessels previously stented.
Lesions located at a bifurcation
lesions involving an epicardial side branch ≥2 mm in diameter by visual assessment
the presence of thrombus or another clinically significant stenosis in the target vessel.
Left main (>50%) or known three vessel disease.
Patients presenting with acute myocardial infarction, unstable arrhythmias, or patients who have a left ventricular ejection fraction <30%
Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.
Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after inclusion.
History of stent thrombosis
Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance
Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided