Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion:a Randomized H215O PET/CT Study
VANISH
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to examine the improvement of myocardial blood flow induced by regained vasomotor functions of the stented coronary segment after resorption of BVS over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedAugust 2, 2016
July 1, 2016
5 years
June 10, 2013
July 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of Myocardial Blood Flow over time
Endothelial dependent vasomotor function and effect on myocardial perfusion
Three years
Secondary Outcomes (1)
Restenosis
Three years
Study Arms (2)
Bioresorbable vascular scaffold
ACTIVE COMPARATORParitcipants will receive a bioresorbable vascular scaffols (BVS)
Xience Prime
ACTIVE COMPARATORParticipant will receive a Xience Prime stent
Interventions
Drug eluting coronary stent, resorbable in 2-3 years
Eligibility Criteria
You may qualify if:
- Patients with documented obstructive CAD by invasive coronary angiography resulting in myocardial ischemia (either documented by invasive (i.e. fractional flow reserve, FFR) or noninvasive imaging techniques (e.g. exercise ECG, myocardial perfusion imaging, or inducibility of wall motion abnormalities during dobutamine stress).
- Presence of a single, de-novo lesion in a native coronary artery (type A or B1), with a reference vessel diameter of at least 3.0 mm and a diameter stenosis of 50% or more and less than 100%, with a thrombolysis in myocardial infarction (TIMI) flow grade of at least 2. Coronary lesion must be amendable for successful treatment with one of the following BRS device dimensions: length 18 or 28 mm, diameter 3.0 or 3.5 mm.
You may not qualify if:
- age of 65 or above
- refusal or inability to provide written informed consent
- other than single CAD
- abnormal echocardiographic findings (i.e. wall motion abnormalities, ventricular hypertrophy, valvular disease etc.)
- complex coronary lesion characteristics (e.g. lesions located in the left main coronary artery, lesions involving a side branch more than 2 mm in diameter, and the presence of thrombus or another clinically significant stenosis in the target vessel)
- poor kidney function defined as an eGFR \< 30 ml/min
- astma or chronic obstructive pulmonary disease
- other than sinus rhythm
- pregnancy
- bail out stenting after placement of the study device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VU University Medical Center
Amsterdam, North Holland, 1081 HV, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Knaapen, MD, PhD
Amsterdam UMC, location VUmc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Drs
Study Record Dates
First Submitted
June 10, 2013
First Posted
June 12, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2018
Last Updated
August 2, 2016
Record last verified: 2016-07