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Trial record 3 of 32 for:    abbott and absorb

ABSORB Post-Approval Clinical Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Abbott Vascular
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT02943616
First received: October 19, 2016
Last updated: October 21, 2016
Last verified: October 2016
  Purpose
The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial designed to observe Absorb continued safety during commercial use in real world settings.

Condition Intervention
Ischemic Heart Disease
Device: Absorb BVS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ABSORB Post-Approval Clinical Study

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Composite of cardiac death, myocardial infarction and scaffold thrombosis (CD/MI/ST) [ Time Frame: 1 year ]
    MI is assessed per the Universal MI definition, and ST is assessed per the Academic Research Consortium (ARC) definite/probable definition.


Secondary Outcome Measures:
  • Percentage of very small vessels (per-lesion basis) [ Time Frame: Pre-procedure (on day 0) ]
    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).

  • Death (Cardiac, Non-Cardiac) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

    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.


  • Death (Cardiac, Non-Cardiac) [ Time Frame: 30 days ]

    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.


  • Death (Cardiac, Non-Cardiac) [ Time Frame: 180 days ]

    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.


  • Death (Cardiac, Non-Cardiac) [ Time Frame: 1 year ]

    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.


  • Death (Cardiac, Non-Cardiac) [ Time Frame: 2 years ]

    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.


  • Death (Cardiac, Non-Cardiac) [ Time Frame: 3 years ]

    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.


  • 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 Vessel Revascularization (TVR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    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.

  • Target Vessel Revascularization (TVR) [ Time Frame: 30 days ]
    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.

  • Target Vessel Revascularization (TVR) [ Time Frame: 180 days ]
    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.

  • Target Vessel Revascularization (TVR) [ Time Frame: 1 year ]
    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.

  • Target Vessel Revascularization (TVR) [ Time Frame: 2 years ]
    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.

  • Target Vessel Revascularization (TVR) [ Time Frame: 3 years ]
    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.

  • 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 ]
  • All coronary revascularization [ Time Frame: 3 years ]
  • Scaffold thrombosis (per ARC definition) [ Time Frame: Acute (0 - 24 hours post stent implantation) (Definite and Probable) ]

    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


  • Scaffold thrombosis (per ARC definition) [ Time Frame: Subacute (>24 hours - 30 days post stent implantation)(Definite and Probable) ]

    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


  • Scaffold thrombosis (per ARC definition) [ Time Frame: Late (30 days - 1 year post stent implantation) (Definite and Probable) ]

    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


  • Scaffold thrombosis (per ARC definition) [ Time Frame: Very late (>1 year post stent implantation) (Definite and Probable) ]

    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


  • Death/All Myocardial Infarction (MI) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    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.

  • Death/All Myocardial Infarction (MI) [ Time Frame: 30 days ]
    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.

  • Death/All Myocardial Infarction (MI) [ Time Frame: 180 days ]
    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.

  • Death/All Myocardial Infarction (MI) [ Time Frame: 1 year ]
    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.

  • Death/All Myocardial Infarction (MI) [ Time Frame: 2 years ]
    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.

  • Death/All Myocardial Infarction (MI) [ Time Frame: 3 years ]
    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.

  • Cardiac Death/All Myocardial Infarction (MI) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    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.

  • Cardiac Death/All Myocardial Infarction (MI) [ Time Frame: 30 days ]
    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.

  • Cardiac Death/All Myocardial Infarction (MI) [ Time Frame: 180 days ]
    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.

  • Cardiac Death/All Myocardial Infarction (MI) [ Time Frame: 1 year ]
    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.

  • Cardiac Death/All Myocardial Infarction (MI) [ Time Frame: 2 years ]
    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.

  • Cardiac Death/All Myocardial Infarction (MI) [ Time Frame: 3 years ]
    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.

  • Cardiac Death/All Myocardial Infarction (MI)/target vessel revascularization (TVR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
  • Cardiac Death/All Myocardial Infarction (MI)/target vessel revascularization (TVR) [ Time Frame: 30 days ]
  • Cardiac Death/All Myocardial Infarction (MI)/target vessel revascularization (TVR) [ Time Frame: 180 days ]
  • Cardiac Death/All Myocardial Infarction (MI)/target vessel revascularization (TVR) [ Time Frame: 1 year ]
  • Cardiac Death/All Myocardial Infarction (MI)/target vessel revascularization (TVR) [ Time Frame: 2 years ]
  • Cardiac Death/All Myocardial Infarction (MI)/target vessel revascularization (TVR) [ Time Frame: 3 years ]
  • Death/All Myocardial Infarction (MI)/All revascularization [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
  • Death/All Myocardial Infarction (MI)/All revascularization [ Time Frame: 30 days ]
  • Death/All Myocardial Infarction (MI)/All revascularization [ Time Frame: 180 days ]
  • Death/All Myocardial Infarction (MI)/All revascularization [ Time Frame: 1 year ]
  • Death/All Myocardial Infarction (MI)/All revascularization [ Time Frame: 2 years ]
  • Death/All Myocardial Infarction (MI)/All revascularization [ Time Frame: 3 years ]

Estimated Enrollment: 3000
Study Start Date: November 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Absorb BVS
Subjects receiving Absorb GT1 Bioresorbable Vascular Scaffold (BVS).
Device: Absorb BVS

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.


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 3000 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 clinical followup will occur at 30 days, 180 days, 1 year, 2 years and 3 years by investigator or designee through telephone contacts or office visits.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject agrees and signs the Institutional Review Board (IRB) approved informed consent form
  • The subject receives an Absorb

Exclusion Criteria:

  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02943616

Contacts
Contact: Billye Guthrie billye.guthrie@av.abbott.com
Contact: Diane Williams diane.williams@av.abbott.com

Locations
United States, Florida
Tallahassee Memorial Hospital Not yet recruiting
Tallahassee, Florida, United States, 32308
Principal Investigator: Wayne Batchelor         
United States, Indiana
Franciscan St. Francis Health Not yet recruiting
Indianapolis, Indiana, United States, 46237
Principal Investigator: Saeed Shaikh, MD         
United States, Kentucky
Baptist Health Louisville Not yet recruiting
Louisville, Kentucky, United States, 40207
Principal Investigator: Thomas Tu         
United States, New Jersey
Englewood Hospital and Medical Center Not yet recruiting
Englewood, New Jersey, United States, 07631
Principal Investigator: Joseph DeGregorio         
United States, Tennessee
Turkey Creek Medical Center Not yet recruiting
Knoxville, Tennessee, United States, 37934
Principal Investigator: Malcolm Foster         
Sponsors and Collaborators
Abbott Vascular
Investigators
Study Director: Peter Staehr Abbott Vascular
  More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT02943616     History of Changes
Other Study ID Numbers: 15-307
Study First Received: October 19, 2016
Last Updated: October 21, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Abbott Vascular:
Absorb GT1 BVS
BVS
Bioabsorbable
Myocardial ischemia
Stent thrombosis
Stents

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 25, 2017