Ischemic Heart DiseaseNCT02943616
ABSORB Post-Approval Clinical Study
A study testing Absorb BVS in people with Ischemic Heart Disease, run by Abbott Medical Devices at 5 sites in United States.
Trial summary
The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world setting following commercial physician training'and to observe the effectiveness of commercial physician training on appropriate vessel sizing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart 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
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2017to Jan 2021
- 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
- The subject agrees and signs the Institutional Review Board (IRB) approved informed consent form
- The subject receives an Absorb
Who cannot join
- Subject is a member of a vulnerable population.
- Vulnerable population: Defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: Individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Franciscan St. Francis Health
Indianapolis, Indiana, 46237
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Baptist Health Louisville
Louisville, Kentucky, 40207
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
About this study
The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world setting following commercial physician training'and to observe the effectiveness of commercial physician training on appropriate vessel sizing.
Read the detailed description
After approval of commercial use of Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System in over 75 countries as of December 31, 2015, Abbott Vascular has developed a post-approval commitment plan that includes the initiation of the ABSORB Post-Approval Clinical Study, a single-arm trial that will include approximately 2000 subjects at approximately 265 sites in the US and Canada.
The objectives of ABSORB PostApproval Study are the following:
- Evaluate the safety of the use of Absorb in a real world setting following commercial physician training.
- Observe the effectiveness of commercial physician training on appropriate vessel sizing in the use of Absorb in a real world setting.
The study design allows evaluating low frequency events, effectiveness of commercial physician training and education for very small vessels (< 2.25 mm as assessed by quantitative coronary angiography [QCA]), and confirmation of generalizability of the treatment with Absorb to real-world practice. The estimated follow-up of safety and effectiveness will be 3 years.
Angiographic Subgroup:
Approximately the first 500 consecutive subjects implanted by operators inexperienced in the usage of Absorb GT1 BVS to receive baseline assessment of reference vessel diameter (RVD) by the angiographic core laboratory. An inexperienced operator is defined as having performed two or fewer Absorb implants prior to commercial approval. The purpose of the angiographic subgroup is to evaluate the effectiveness of training in the selection of appropriately sized coronary arteries for GT1 BVS implantation. Study staff will be notified after the procedure if the subject is in the angiographic subgroup, and instructed to send pre-procedure angiogram and supporting materials to core laboratory for assessment.
- Conditions
- Ischemic Heart Disease
- Being tested
- Absorb BVS
- Keywords
- Absorb GT1 BVS, BVS, Bioabsorbable, Myocardial ischemia, Stent thrombosis, Stents
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorb BVSDevice
Commercially approved Absorb GT1 BVS, herein referred to as "Absorb".
- Scaffold diameters: 2.5, 3.0, and 3.5 mm
- Scaffold lengths: 8, 12, 18, 23 and 28 mm
Absorb is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
| Study group | Role | What they receive |
|---|---|---|
| Absorb BVS | Experimental | Subjects receiving Absorb GT1 Bioresorbable Vascular Scaffold (BVS). Receives: Device: Absorb BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiac death, myocardial infarction (CD/MI)
Myocardial infarction will be assessed per the Universal MI definition.
Measured: 1 year
Secondary outcomes (75)
Definite/probable scaffold thrombosis (ST)
ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.
Measured: 1 year
The annual rate of definite/probable scaffold thrombosis
ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.
Measured: At 1 year post-index procedure
The annual rate of definite/probable scaffold thrombosis
ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.
Measured: Between 1 year and 2 years (366 to 730 days) post index procedure
The annual rate of definite/probable scaffold thrombosis
ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.
Measured: Between 2 years and 3 years (731 to 1095 days) post index procedure
Percentage of very small vessels (per-lesion basis)
This is the commercial Training Assessment Endpoint (Angiographic Subgroup only). Pre-procedure reference vessel diameter (RVD) < 2.25 mm as assessed by core laboratory using quantitative coronary angiography (QCA).
Measured: Pre-procedure (on day 0)
Death (Cardiac, Non-Cardiac)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: ≤ 7 days post index procedure (In-hospital )
Death (Cardiac, Non-Cardiac)
Measured: 30 days
Death (Cardiac, Non-Cardiac)
Measured: 180 days
Death (Cardiac, Non-Cardiac)
Measured: 1 year
Death (Cardiac, Non-Cardiac)
Measured: 2 years
Death (Cardiac, Non-Cardiac)
Measured: 3 years
All Myocardial Infarction (All MI)
Measured: ≤ 7 days post index procedure (In-hospital )
All Myocardial Infarction (All MI)
Measured: 30 days
All Myocardial Infarction (All MI)
Measured: 180 days
All Myocardial Infarction (All MI)
Measured: 1 year
All Myocardial Infarction (All MI)
Measured: 2 years
All Myocardial Infarction (All MI)
Measured: 3 years
Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Measured: ≤ 7 days post index procedure (In-hospital )
Target Lesion Revascularization (TLR)
Measured: 30 days
Target Lesion Revascularization (TLR)
Measured: 180 days
Target Lesion Revascularization (TLR)
Measured: 1 year
Target Lesion Revascularization (TLR)
Measured: 2 years
Target Lesion Revascularization (TLR)
Measured: 3 years
Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Measured: ≤ 7 days post index procedure (In-hospital )
Ischemia Driven TLR (ID-TLR)
Measured: 30 days
Ischemia Driven TLR (ID-TLR)
Measured: 180 days
Ischemia Driven TLR (ID-TLR)
Measured: 1 year
Ischemia Driven TLR (ID-TLR)
Measured: 2 years
Ischemia Driven TLR (ID-TLR)
Measured: 3 years
Target Vessel Revascularization (TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: ≤ 7 days post index procedure (In-hospital )
Target Vessel Revascularization (TVR)
Measured: 30 days
Target Vessel Revascularization (TVR)
Measured: 180 days
Target Vessel Revascularization (TVR)
Measured: 1 year
Target Vessel Revascularization (TVR)
Measured: 2 years
Target Vessel Revascularization (TVR)
Measured: 3 years
All coronary revascularization
Measured: ≤ 7 days post index procedure (In-hospital )
All coronary revascularization
Measured: 30 days
All coronary revascularization
Measured: 180 days
All coronary revascularization
Measured: 1 year
All coronary revascularization
Measured: 2 years
All coronary revascularization
Measured: 3 years
Scaffold thrombosis (per ARC definition)
Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: Acute (0 - 24 hours post stent implantation) (Definite and Probable)
Scaffold thrombosis (per ARC definition)
Measured: Subacute (>24 hours - 30 days post stent implantation)(Definite and Probable)
Scaffold thrombosis (per ARC definition)
Measured: Late (30 days - 1 year post stent implantation) (Definite and Probable)
Scaffold thrombosis (per ARC definition)
Measured: Very late (>1 year post stent implantation) (Definite and Probable)
Death/All Myocardial Infarction (MI)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Measured: ≤ 7 days post index procedure (In-hospital )
Death/All Myocardial Infarction (MI)
Measured: 30 days
Death/All Myocardial Infarction (MI)
Measured: 180 days
Death/All Myocardial Infarction (MI)
Measured: 1 year
Death/All Myocardial Infarction (MI)
Measured: 2 years
Death/All Myocardial Infarction (MI)
Measured: 3 years
Cardiac Death/All Myocardial Infarction (MI)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: ≤ 7 days post index procedure (In-hospital )
Cardiac Death/All Myocardial Infarction (MI)
Measured: 30 days
Cardiac Death/All Myocardial Infarction (MI)
Measured: 180 days
Cardiac Death/All Myocardial Infarction (MI)
Measured: 1 year
Cardiac Death/All Myocardial Infarction (MI)
Measured: 2 years
Cardiac Death/All Myocardial Infarction (MI)
Measured: 3 years
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [Target vessel failure;TVF]
Measured: ≤ 7 days post index procedure (In-hospital )
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Measured: 30 days
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Measured: 180 days
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Measured: 1 year
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Measured: 2 years
Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
Measured: 3 years
Cardiac Death/TV MI/ID-TLR (Target lesion failure;TLF)
Measured: ≤ 7 days post index procedure (In-hospital )
Cardiac Death/TV MI/ID-TLR (TLF)
Measured: 30 days
Cardiac Death/TV MI/ID-TLR (TLF)
Measured: 180 days
Cardiac Death/TV MI/ID-TLR (TLF)
Measured: 1 year
Cardiac Death/TV MI/ID-TLR (TLF)
Measured: 2 years
Cardiac Death/TV MI/ID-TLR (TLF)
Measured: 3 years
Death/All Myocardial Infarction (MI)/All revascularization
Measured: ≤ 7 days post index procedure (In-hospital )
Death/All Myocardial Infarction (MI)/All revascularization
Measured: 30 days
Death/All Myocardial Infarction (MI)/All revascularization
Measured: 180 days
Death/All Myocardial Infarction (MI)/All revascularization
Measured: 1 year
Death/All Myocardial Infarction (MI)/All revascularization
Measured: 2 years
Death/All Myocardial Infarction (MI)/All revascularization
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startAug 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Abbott has decided to stop selling the Absorb stent which was the product under evaluation in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Staehr, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943616
- Sponsor's protocol ID
- 15-307
- Status last verified
- Jan 2018
- First submitted
- 19 Oct 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABSORB Post-Approval Clinical Study
- ClinicalTrials.gov ID
- NCT02943616
- Acronym / sponsor ID
- 15-307
- Conditions
- Ischemic Heart Disease
- Keywords
- Absorb GT1 BVS, BVS, Bioabsorbable, Myocardial ischemia, Stent thrombosis, Stents
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Abbott has decided to stop selling the Absorb stent which was the product under evaluation in this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 25 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 ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world setting following commercial physician training'and to observe the effectiveness of commercial physician training on appropriate vessel sizing.
Detailed description
After approval of commercial use of Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System in over 75 countries as of December 31, 2015, Abbott Vascular has developed a post-approval commitment plan that includes the initiation of the ABSORB Post-Approval Clinical Study, a single-arm trial that will include approximately 2000 subjects at approximately 265 sites in the US and Canada.
The objectives of ABSORB PostApproval Study are the following:
- Evaluate the safety of the use of Absorb in a real world setting following commercial physician training.
- Observe the effectiveness of commercial physician training on appropriate vessel sizing in the use of Absorb in a real world setting.
The study design allows evaluating low frequency events, effectiveness of commercial physician training and education for very small vessels (< 2.25 mm as assessed by quantitative coronary angiography [QCA]), and confirmation of generalizability of the treatment with Absorb to real-world practice. The estimated follow-up of safety and effectiveness will be 3 years.
Angiographic Subgroup:
Approximately the first 500 consecutive subjects implanted by operators inexperienced in the usage of Absorb GT1 BVS to receive baseline assessment of reference vessel diameter (RVD) by the angiographic core laboratory. An inexperienced operator is defined as having performed two or fewer Absorb implants prior to commercial approval. The purpose of the angiographic subgroup is to evaluate the effectiveness of training in the selection of appropriately sized coronary arteries for GT1 BVS implantation. Study staff will be notified after the procedure if the subject is in the angiographic subgroup, and instructed to send pre-procedure angiogram and supporting materials to core laboratory for assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Absorb BVS | Experimental | Device: Absorb BVSSubjects receiving Absorb GT1 Bioresorbable Vascular Scaffold (BVS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject agrees and signs the Institutional Review Board (IRB) approved informed consent form
- The subject receives an Absorb
Key exclusion criteria (2 listed)
- Subject is a member of a vulnerable population.
- Vulnerable population: Defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: Individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention
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 BVSCommercially approved Absorb GT1 BVS, herein referred to as "Absorb". * Scaffold diameters: 2.5, 3.0, and 3.5 mm * Scaffold lengths: 8, 12, 18, 23 and 28 mm Absorb is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. | Device | Absorb BVS |
Primary outcome
Composite of cardiac death, myocardial infarction (CD/MI)
Time frame: 1 year
Myocardial infarction will be assessed per the Universal MI definition.
75 secondary outcomes
Definite/probable scaffold thrombosis (ST)
Time frame: 1 year
The annual rate of definite/probable scaffold thrombosis
Time frame: At 1 year post-index procedure
The annual rate of definite/probable scaffold thrombosis
Time frame: Between 1 year and 2 years (366 to 730 days) post index procedure
The annual rate of definite/probable scaffold thrombosis
Time frame: Between 2 years and 3 years (731 to 1095 days) post index procedure
Percentage of very small vessels (per-lesion basis)
Time frame: Pre-procedure (on day 0)
Death (Cardiac, Non-Cardiac)
Time frame: ≤ 7 days post index procedure (In-hospital )
Death (Cardiac, Non-Cardiac)
Time frame: 30 days
Death (Cardiac, Non-Cardiac)
Time frame: 180 days
Death (Cardiac, Non-Cardiac)
Time frame: 1 year
Death (Cardiac, Non-Cardiac)
Time frame: 2 years
Death (Cardiac, Non-Cardiac)
Time frame: 3 years
All Myocardial Infarction (All MI)
Time frame: ≤ 7 days post index procedure (In-hospital )
All Myocardial Infarction (All MI)
Time frame: 30 days
All Myocardial Infarction (All MI)
Time frame: 180 days
All Myocardial Infarction (All MI)
Time frame: 1 year
All Myocardial Infarction (All MI)
Time frame: 2 years
All Myocardial Infarction (All MI)
Time frame: 3 years
Target Lesion Revascularization (TLR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Target Lesion Revascularization (TLR)
Time frame: 30 days
Target Lesion Revascularization (TLR)
Time frame: 180 days
Target Lesion Revascularization (TLR)
Time frame: 1 year
Target Lesion Revascularization (TLR)
Time frame: 2 years
Target Lesion Revascularization (TLR)
Time frame: 3 years
Ischemia Driven TLR (ID-TLR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Ischemia Driven TLR (ID-TLR)
Time frame: 30 days
Ischemia Driven TLR (ID-TLR)
Time frame: 180 days
Ischemia Driven TLR (ID-TLR)
Time frame: 1 year
Ischemia Driven TLR (ID-TLR)
Time frame: 2 years
Ischemia Driven TLR (ID-TLR)
Time frame: 3 years
Target Vessel Revascularization (TVR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Target Vessel Revascularization (TVR)
Time frame: 30 days
Target Vessel Revascularization (TVR)
Time frame: 180 days
Target Vessel Revascularization (TVR)
Time frame: 1 year
Target Vessel Revascularization (TVR)
Time frame: 2 years
Target Vessel Revascularization (TVR)
Time frame: 3 years
All coronary revascularization
Time frame: ≤ 7 days post index procedure (In-hospital )
All coronary revascularization
Time frame: 30 days
All coronary revascularization
Time frame: 180 days
All coronary revascularization
Time frame: 1 year
All coronary revascularization
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Ischemic Heart Disease
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
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.
Peter Staehr study director
Abbott Medical Devices
5 sites 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 Ischemic Heart Disease, run by Abbott Medical Devices at 5 sites in United States.
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 2 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: withdrawn, as of the sponsor's last update on 11 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 5 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Composite of cardiac death, myocardial infarction (CD/MI) (time frame: 1 year). 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 11 Jan 2018.