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Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold

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ClinicalTrials.gov Identifier: NCT02319733
Recruitment Status : Terminated (insufficient eligable subjects and new data on BVS)
First Posted : December 18, 2014
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
M.E.R. Gomes, Canisius-Wilhelmina Hospital

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.

Condition or disease Intervention/treatment Phase
Vulnerable Plaque Device: Bioresorbable vascular scaffold Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Plaque Stabilization and Restoration of Vascular Function by Bioresorbable Vascular Scaffold in Acute Coronary Syndrome Prone Patients
Study Start Date : December 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Bioresorbable vascular scaffold
Implantation of Bioresorbable vascular scaffold in vulnerable plaques
Device: Bioresorbable vascular scaffold
Implantation of Bioresorbable vascular scaffold in vulnerable plaques




Primary Outcome Measures :
  1. change in plaque cumulative score of signs of vulnerability on CT [ Time Frame: 24 months ]
  2. nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319733


Locations
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Netherlands
Canisuis Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands, 6532 SZ
Sponsors and Collaborators
Canisius-Wilhelmina Hospital

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Responsible Party: M.E.R. Gomes, dr., Canisius-Wilhelmina Hospital
ClinicalTrials.gov Identifier: NCT02319733     History of Changes
Other Study ID Numbers: 2013/498
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017