Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion:a Randomized H215O PET/CT Study (VANISH)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bioresorbable vascular scaffold
Xience Prime
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease (CAD), Invasive coronary angiography (ICA), Positron Emission Tomography (PET)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- VU University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bioresorbable vascular scaffold
Xience Prime
Arm Description
Paritcipants will receive a bioresorbable vascular scaffols (BVS)
Participant will receive a Xience Prime stent
Outcomes
Primary Outcome Measures
Evaluation of Myocardial Blood Flow over time
Endothelial dependent vasomotor function and effect on myocardial perfusion
Secondary Outcome Measures
Restenosis
Obstructive coronary lesions and lumen dimensions on control invasive coronary angiogram that may affect the MBF measurements
Full Information
NCT ID
NCT01876589
First Posted
June 10, 2013
Last Updated
July 30, 2016
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT01876589
Brief Title
Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion:a Randomized H215O PET/CT Study
Acronym
VANISH
Official Title
Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: a Randomized H215O PET/CT Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Objective The objective of the proposed study is to determine the impact of VRT, in comparison with conventional drug-eluting stenting, on endothelium dependent vasodilation and maximal hyperemic myocardial perfusion using H215O PET.
Study design The study is designed as a single center single-blind randomized clinical trial and will be conducted at the VU University Medical Center in Amsterdam.
Summary of the study design It is hypothesized that VRT will result in augmented endothelium dependent coronary vasodilation and maximal myocardial perfusion as compared with conventional stenting of a coronary lesion. Within one year sixty patients (age 18-65) with documented single vessel CAD (type A or B1 lesion) accepted for PCI based on clinical grounds and according to current international guidelines, will be asked to participate in this trial. Patients will be randomized to implantation of a drug-eluted stent (Xience Prime) or BRS (Absorb). The patients will be blinded to the nature of the implanted device. H2 15O PET will be performed one month (reference scan), one year, and three years after the PCI procedure (resolution of BRS is generally complete within a three year period). The PET protocol will consist of three MBF measurements: resting MBF, during endothelial dependent vasodilation provoked by coldpressor-testing (CPT), and during (endothelial dependent and independent) maximal vasodilation by infusion of adenosine intravenously. After three years a control invasive coronary angiogram will document any potential obstructive coronary lesions that may affect the MBF measurements.
Primary study parameters/outcome of the study MBF measurements: resting MBF, during endothelial dependent vasodilation provoked by cold-pressor-testing (CPT), and during (endothelial dependent and independent) maximal vasodilation by infusion of adenosine intravenously
Secondary study parameters/outcome of the study Obstructive coronary lesions on control invasive coronary angiogram that may affect the MBF measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease (CAD), Invasive coronary angiography (ICA), Positron Emission Tomography (PET)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bioresorbable vascular scaffold
Arm Type
Active Comparator
Arm Description
Paritcipants will receive a bioresorbable vascular scaffols (BVS)
Arm Title
Xience Prime
Arm Type
Active Comparator
Arm Description
Participant will receive a Xience Prime stent
Intervention Type
Device
Intervention Name(s)
Bioresorbable vascular scaffold
Intervention Description
Drug eluting coronary stent, resorbable in 2-3 years
Intervention Type
Device
Intervention Name(s)
Xience Prime
Intervention Description
Drug eluting metallic stent
Primary Outcome Measure Information:
Title
Evaluation of Myocardial Blood Flow over time
Description
Endothelial dependent vasomotor function and effect on myocardial perfusion
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Restenosis
Description
Obstructive coronary lesions and lumen dimensions on control invasive coronary angiogram that may affect the MBF measurements
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Knaapen, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion:a Randomized H215O PET/CT Study
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