Coronary Artery DiseaseVANISHNCT01876589
Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion:a Randomized H215O PET/CT Study
A study testing Bioresorbable vascular scaffold and Xience Prime in people with Coronary Artery Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Bioresorbable vascular scaffold and Xience Prime
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- astma or chronic obstructive pulmonary disease
- other than sinus rhythm
- pregnancy
- bail out stenting after placement of the study device
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081 HV
About this study
Official title: Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: a Randomized H215O PET/CT Study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Bioresorbable vascular scaffold, Xience Prime
- Keywords
- Coronary Artery Disease (CAD), Invasive coronary angiography (ICA), Positron Emission Tomography (PET)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable vascular scaffoldDevice
Drug eluting coronary stent, resorbable in 2-3 years
Xience PrimeDevice
Drug eluting metallic stent
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable vascular scaffold | Active comparator | Paritcipants will receive a bioresorbable vascular scaffols (BVS) Receives: Device: Bioresorbable vascular scaffold |
| Xience Prime | Active comparator | Participant will receive a Xience Prime stent Receives: Device: Xience Prime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Myocardial Blood Flow over time
Endothelial dependent vasomotor function and effect on myocardial perfusion
Measured: Three years
Secondary outcomes (1)
Restenosis
Obstructive coronary lesions and lumen dimensions on control invasive coronary angiogram that may affect the MBF measurements
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wynand Stuijfzand, Amsterdam UMC, location VUmc
- Investigators
- Paul Knaapen, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876589
- Sponsor's protocol ID
- VANISH
- Acronym
- VANISH
- Status last verified
- Jul 2016
- First submitted
- 10 Jun 2013
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: a Randomized H215O PET/CT Study
- ClinicalTrials.gov ID
- NCT01876589
- Acronym / sponsor ID
- VANISH / VANISH
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease (CAD), Invasive coronary angiography (ICA), Positron Emission Tomography (PET)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2018 (estimated)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable vascular scaffold | Active comparator | Device: Bioresorbable vascular scaffoldParitcipants will receive a bioresorbable vascular scaffols (BVS) |
| Xience Prime | Active comparator | Device: Xience PrimeParticipant will receive a Xience Prime stent |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioresorbable vascular scaffoldDrug eluting coronary stent, resorbable in 2-3 years | Device | Bioresorbable vascular scaffold |
| Xience PrimeDrug eluting metallic stent | Device | Xience Prime |
Primary outcome
Evaluation of Myocardial Blood Flow over time
Time frame: Three years
Endothelial dependent vasomotor function and effect on myocardial perfusion
1 secondary outcome
Restenosis
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Knaapen, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioresorbable vascular scaffold and Xience Prime in people with Coronary Artery Disease, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Myocardial Blood Flow over time (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.