Clinical trial NCT02943616: ABSORB Post-Approval Clinical Study
Official title: ABSORB Post-Approval Clinical Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Absorb GT1 BVS
BVS
Bioabsorbable
Myocardial ischemia
Stent thrombosis
Stents
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Composite of cardiac death, myocardial infarction (CD/MI)
timeFrame: 1 year
Secondary outcomes:
measure: Definite/probable scaffold thrombosis (ST)
timeFrame: 1 year
measure: The annual rate of definite/probable scaffold thrombosis
timeFrame: At 1 year post-index procedure
measure: The annual rate of definite/probable scaffold thrombosis
timeFrame: Between 1 year and 2 years (366 to 730 days) post index procedure
measure: The annual rate of definite/probable scaffold thrombosis
timeFrame: Between 2 years and 3 years (731 to 1095 days) post index procedure
measure: Percentage of very small vessels (per-lesion basis)
timeFrame: Pre-procedure (on day 0)
measure: Death (Cardiac, Non-Cardiac)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Death (Cardiac, Non-Cardiac)
timeFrame: 30 days
measure: Death (Cardiac, Non-Cardiac)
timeFrame: 180 days
measure: Death (Cardiac, Non-Cardiac)
timeFrame: 1 year
measure: Death (Cardiac, Non-Cardiac)
timeFrame: 2 years
measure: Death (Cardiac, Non-Cardiac)
timeFrame: 3 years
measure: All Myocardial Infarction (All MI)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: All Myocardial Infarction (All MI)
timeFrame: 30 days
measure: All Myocardial Infarction (All MI)
timeFrame: 180 days
measure: All Myocardial Infarction (All MI)
timeFrame: 1 year
measure: All Myocardial Infarction (All MI)
timeFrame: 2 years
measure: All Myocardial Infarction (All MI)
timeFrame: 3 years
measure: Target Lesion Revascularization (TLR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Target Lesion Revascularization (TLR)
timeFrame: 30 days
measure: Target Lesion Revascularization (TLR)
timeFrame: 180 days
measure: Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: Target Lesion Revascularization (TLR)
timeFrame: 2 years
measure: Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Ischemia Driven TLR (ID-TLR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Ischemia Driven TLR (ID-TLR)
timeFrame: 30 days
measure: Ischemia Driven TLR (ID-TLR)
timeFrame: 180 days
measure: Ischemia Driven TLR (ID-TLR)
timeFrame: 1 year
measure: Ischemia Driven TLR (ID-TLR)
timeFrame: 2 years
measure: Ischemia Driven TLR (ID-TLR)
timeFrame: 3 years
measure: Target Vessel Revascularization (TVR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Target Vessel Revascularization (TVR)
timeFrame: 30 days
measure: Target Vessel Revascularization (TVR)
timeFrame: 180 days
measure: Target Vessel Revascularization (TVR)
timeFrame: 1 year
measure: Target Vessel Revascularization (TVR)
timeFrame: 2 years
measure: Target Vessel Revascularization (TVR)
timeFrame: 3 years
measure: All coronary revascularization
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: All coronary revascularization
timeFrame: 30 days
measure: All coronary revascularization
timeFrame: 180 days
measure: All coronary revascularization
timeFrame: 1 year
measure: All coronary revascularization
timeFrame: 2 years
measure: All coronary revascularization
timeFrame: 3 years
measure: Scaffold thrombosis (per ARC definition)
timeFrame: Acute (0 - 24 hours post stent implantation) (Definite and Probable)
measure: Scaffold thrombosis (per ARC definition)
timeFrame: Subacute (>24 hours - 30 days post stent implantation)(Definite and Probable)
measure: Scaffold thrombosis (per ARC definition)
timeFrame: Late (30 days - 1 year post stent implantation) (Definite and Probable)
measure: Scaffold thrombosis (per ARC definition)
timeFrame: Very late (>1 year post stent implantation) (Definite and Probable)
measure: Death/All Myocardial Infarction (MI)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Death/All Myocardial Infarction (MI)
timeFrame: 30 days
measure: Death/All Myocardial Infarction (MI)
timeFrame: 180 days
measure: Death/All Myocardial Infarction (MI)
timeFrame: 1 year
measure: Death/All Myocardial Infarction (MI)
timeFrame: 2 years
measure: Death/All Myocardial Infarction (MI)
timeFrame: 3 years
measure: Cardiac Death/All Myocardial Infarction (MI)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Cardiac Death/All Myocardial Infarction (MI)
timeFrame: 30 days
measure: Cardiac Death/All Myocardial Infarction (MI)
timeFrame: 180 days
measure: Cardiac Death/All Myocardial Infarction (MI)
timeFrame: 1 year
measure: Cardiac Death/All Myocardial Infarction (MI)
timeFrame: 2 years
measure: Cardiac Death/All Myocardial Infarction (MI)
timeFrame: 3 years
measure: Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [Target vessel failure;TVF]
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
timeFrame: 30 days
measure: Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
timeFrame: 180 days
measure: Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
timeFrame: 1 year
measure: Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
timeFrame: 2 years
measure: Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF]
timeFrame: 3 years
measure: Cardiac Death/TV MI/ID-TLR (Target lesion failure;TLF)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Cardiac Death/TV MI/ID-TLR (TLF)
timeFrame: 30 days
measure: Cardiac Death/TV MI/ID-TLR (TLF)
timeFrame: 180 days
measure: Cardiac Death/TV MI/ID-TLR (TLF)
timeFrame: 1 year
measure: Cardiac Death/TV MI/ID-TLR (TLF)
timeFrame: 2 years
measure: Cardiac Death/TV MI/ID-TLR (TLF)
timeFrame: 3 years
measure: Death/All Myocardial Infarction (MI)/All revascularization
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Death/All Myocardial Infarction (MI)/All revascularization
timeFrame: 30 days
measure: Death/All Myocardial Infarction (MI)/All revascularization
timeFrame: 180 days
measure: Death/All Myocardial Infarction (MI)/All revascularization
timeFrame: 1 year
measure: Death/All Myocardial Infarction (MI)/All revascularization
timeFrame: 2 years
measure: Death/All Myocardial Infarction (MI)/All revascularization
timeFrame: 3 years
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
Study officials:
affiliation: Abbott Medical Devices
name: Peter Staehr
role: STUDY_DIRECTOR
References: