Myocardial IschemiaBISORB OCTNCT02928198
Bifurcation ABSORB OCT Trial
A study testing ABSORB BVS in people with Myocardial Ischemia and Ischemia, run by J.J. Wykrzykowska at 1 site in Netherlands.
Trial summary
The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive subjects with and without fenestration towards… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Ischemia, Coronary Disease
- What is being tested?
- ABSORB BVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2016to Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded).
- Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography.
- Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure,as approved by the appropriate Ethics Committee.
Who cannot join
- Subject is younger than 18 years of age
- Subject is presenting with a STEMI
- Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
- Subject has known hypersensitivity or contraindication to contrast, aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
- Subject with a limited life expectancy less than one year.
- Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or subject unable to read or write.
Trial locations and contacts
1 site in 1 country.
About this study
The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive subjects with and without fenestration towards the side branch.
Patients included in this study will be divided into three different cohorts:
Read more
- Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.
- Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.
- Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.
All patients will also have telephone FU at 30 days, 12, 24 and 36 months.
Inclusion of patients in the BISORB OCT trial stopped in November 2016 after safety concerns of the ABSORB BVS were reported. BISORB OCT included 3 patients, which were all included in the Academic Medical Center
- Conditions
- Myocardial Ischemia, Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Coronary Bifurcation Lesions
- Being tested
- ABSORB BVS
- Keywords
- Tomography, Optical Coherence, Percutaneous Coronary Intervention, Cardiac Catheterization, Coronary Biovascular Scaffold
- Medical subject headings
- Myocardial Ischemia, Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Infarction, Myocardial Infarction, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSORB BVSDevice
| Study group | Role | What they receive |
|---|---|---|
| Fenestration | Active comparator | Fenestration of the Absorb Biovascular Scaffold towards the side-branch Receives: Device: ABSORB BVS |
| No Fenestration | Active comparator | No fenestration of the Absorb Biovascular Scaffold towards the side-branch Receives: Device: ABSORB BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A
3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.
Measured: 12 months
Secondary outcomes (36)
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts
3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.
Measured: Baseline
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B
3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.
Measured: 24 months
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C
3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.
Measured: 36 months
Incomplete strut apposition in the bifurcation region - All cohorts
Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.
Measured: Baseline
Incomplete strut apposition in the bifurcation region - Cohort A
Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.
Measured: 12 months
Incomplete strut apposition in the bifurcation region - Cohort B
Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.
Measured: 24 months
Incomplete strut apposition in the bifurcation region - Cohort C
Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.
Measured: 36 months
Number of embedded and protruded ABSORB BVS struts per region - All cohorts
Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
Measured: Baseline
Number of embedded and protruded ABSORB BVS struts per region - Cohort A
Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
Measured: 12 months
Number of embedded and protruded ABSORB BVS struts per region - Cohort B
Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
Measured: 24 months
Number of embedded and protruded ABSORB BVS struts per region - Cohort C
Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
Measured: 36 months
Incomplete strut coverage in the bifurcation region - Cohort A
Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.
Measured: 12 months
Incomplete strut coverage in the bifurcation region - Cohort B
Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.
Measured: 24 months
Incomplete strut coverage in the bifurcation region - Cohort C
Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.
Measured: 36 months
The number of non-apposed side branch (NASB) struts - All cohorts
Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
Measured: Baseline
The number of non-apposed side branch (NASB) struts - Cohort A
Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
Measured: 12 months
The number of non-apposed side branch (NASB) struts - Cohort B
Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
Measured: 24 months
The number of non-apposed side branch (NASB) struts - Cohort C
Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
Measured: 36 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort A
Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
Measured: 12 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort B
Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
Measured: 24 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort C
Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
Measured: 36 months
Mean/Minimal Lumen diameter/area - All cohorts
Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area
Measured: Baseline
Mean/Minimal Lumen diameter/area - Cohort A
Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area
Measured: 12 months
Mean/Minimal Lumen diameter/area - Cohort B
Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area
Measured: 24 months
Mean/Minimal Lumen diameter/area - Cohort C
Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area
Measured: 36 months
Mean/Minimal Scaffold diameter/area - All cohorts
Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.
Measured: Baseline
Mean/Minimal Scaffold diameter/area - Cohort A
Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.
Measured: 12 months
Mean/Minimal Scaffold diameter/area - Cohort B
Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.
Measured: 24 months
Mean/Minimal Scaffold diameter/area - Cohort C
Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.
Measured: 36 months
Neointima thickness - Cohort A
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
Measured: 12 months
Neointima thickness - Cohort B
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
Measured: 24 months
Neointima thickness - Cohort C
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
Measured: 36 months
Scaffold pattern irregularities - All cohorts
Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.
Measured: Baseline
Scaffold pattern irregularities - Cohort A
Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.
Measured: 12 months
Scaffold pattern irregularities - Cohort B
Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.
Measured: 24 months
Scaffold pattern irregularities - Cohort C
Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- J.J. Wykrzykowska
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor-investigator, J.J. Wykrzykowska, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Joanna J Wykrzykowska, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928198
- Sponsor's protocol ID
- NL50172.018.14
- Acronym
- BISORB OCT
- Status last verified
- Jan 2018
- First submitted
- 9 Sep 2016
- Last updated
- 17 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bifurcation ABSORB OCT Trial
- ClinicalTrials.gov ID
- NCT02928198
- Acronym / sponsor ID
- BISORB OCT / NL50172.018.14
- Conditions
- Myocardial Ischemia, Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Coronary Bifurcation Lesions
- Keywords
- Tomography, Optical Coherence, Percutaneous Coronary Intervention, Cardiac Catheterization, Coronary Biovascular Scaffold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- J.J. WykrzykowskaUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jun 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 10 Oct 2016 (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 Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive subjects with and without fenestration towards the side branch.
Patients included in this study will be divided into three different cohorts:
- Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.
- Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.
- Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.
All patients will also have telephone FU at 30 days, 12, 24 and 36 months.
Inclusion of patients in the BISORB OCT trial stopped in November 2016 after safety concerns of the ABSORB BVS were reported. BISORB OCT included 3 patients, which were all included in the Academic Medical Center
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenestration | Active comparator | Device: ABSORB BVSFenestration of the Absorb Biovascular Scaffold towards the side-branch |
| No Fenestration | Active comparator | Device: ABSORB BVSNo fenestration of the Absorb Biovascular Scaffold towards the side-branch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded).
- Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography.
- Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure,as approved by the appropriate Ethics Committee.
Key exclusion criteria (7 listed)
- Subject is younger than 18 years of age
- Subject is presenting with a STEMI
- Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
- Subject has known hypersensitivity or contraindication to contrast, aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
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 |
|---|---|---|
| ABSORB BVS | Device | Fenestration, No Fenestration |
Primary outcome
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A
Time frame: 12 months
3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.
36 secondary outcomes
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts
Time frame: Baseline
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B
Time frame: 24 months
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C
Time frame: 36 months
Incomplete strut apposition in the bifurcation region - All cohorts
Time frame: Baseline
Incomplete strut apposition in the bifurcation region - Cohort A
Time frame: 12 months
Incomplete strut apposition in the bifurcation region - Cohort B
Time frame: 24 months
Incomplete strut apposition in the bifurcation region - Cohort C
Time frame: 36 months
Number of embedded and protruded ABSORB BVS struts per region - All cohorts
Time frame: Baseline
Number of embedded and protruded ABSORB BVS struts per region - Cohort A
Time frame: 12 months
Number of embedded and protruded ABSORB BVS struts per region - Cohort B
Time frame: 24 months
Number of embedded and protruded ABSORB BVS struts per region - Cohort C
Time frame: 36 months
Incomplete strut coverage in the bifurcation region - Cohort A
Time frame: 12 months
Incomplete strut coverage in the bifurcation region - Cohort B
Time frame: 24 months
Incomplete strut coverage in the bifurcation region - Cohort C
Time frame: 36 months
The number of non-apposed side branch (NASB) struts - All cohorts
Time frame: Baseline
The number of non-apposed side branch (NASB) struts - Cohort A
Time frame: 12 months
The number of non-apposed side branch (NASB) struts - Cohort B
Time frame: 24 months
The number of non-apposed side branch (NASB) struts - Cohort C
Time frame: 36 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort A
Time frame: 12 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort B
Time frame: 24 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort C
Time frame: 36 months
Mean/Minimal Lumen diameter/area - All cohorts
Time frame: Baseline
Mean/Minimal Lumen diameter/area - Cohort A
Time frame: 12 months
Mean/Minimal Lumen diameter/area - Cohort B
Time frame: 24 months
Mean/Minimal Lumen diameter/area - Cohort C
Time frame: 36 months
Mean/Minimal Scaffold diameter/area - All cohorts
Time frame: Baseline
Mean/Minimal Scaffold diameter/area - Cohort A
Time frame: 12 months
Mean/Minimal Scaffold diameter/area - Cohort B
Time frame: 24 months
Mean/Minimal Scaffold diameter/area - Cohort C
Time frame: 36 months
Neointima thickness - Cohort A
Time frame: 12 months
Neointima thickness - Cohort B
Time frame: 24 months
Neointima thickness - Cohort C
Time frame: 36 months
Scaffold pattern irregularities - All cohorts
Time frame: Baseline
Scaffold pattern irregularities - Cohort A
Time frame: 12 months
Scaffold pattern irregularities - Cohort B
Time frame: 24 months
Scaffold pattern irregularities - Cohort C
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
Joanna J Wykrzykowska, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABSORB BVS in people with Myocardial Ischemia and Ischemia, run by J.J. Wykrzykowska 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 3 inclusion and 7 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 17 Jan 2018. 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?
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A (time frame: 12 months). 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 17 Jan 2018.