Ischemic Heart Disease Clinical Trial
Official title:
ABSORB Post-Approval Clinical Study
Verified date | January 2018 |
Source | Abbott Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2021 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
United States | Franciscan St. Francis Health | Indianapolis | Indiana |
United States | Turkey Creek Medical Center | Knoxville | Tennessee |
United States | Baptist Health Louisville | Louisville | Kentucky |
United States | Tallahassee Memorial Hospital | Tallahassee | Florida |
Lead Sponsor | Collaborator |
---|---|
Abbott Vascular |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of cardiac death, myocardial infarction (CD/MI) | Myocardial infarction will be assessed per the Universal MI definition. | 1 year | |
Secondary | Definite/probable scaffold thrombosis (ST) | ST is assessed per the Academic Research Consortium (ARC) definite/probable definition. | 1 year | |
Secondary | The annual rate of definite/probable scaffold thrombosis | ST is assessed per the Academic Research Consortium (ARC) definite/probable definition. | At 1 year post-index procedure | |
Secondary | The annual rate of definite/probable scaffold thrombosis | ST is assessed per the Academic Research Consortium (ARC) definite/probable definition. | Between 1 year and 2 years (366 to 730 days) post index procedure | |
Secondary | The annual rate of definite/probable scaffold thrombosis | ST is assessed per the Academic Research Consortium (ARC) definite/probable definition. | Between 2 years and 3 years (731 to 1095 days) post index procedure | |
Secondary | 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). | Pre-procedure (on day 0) | |
Secondary | 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. |
= 7 days post index procedure (In-hospital ) | |
Secondary | Death (Cardiac, Non-Cardiac) | 30 days | ||
Secondary | Death (Cardiac, Non-Cardiac) | 180 days | ||
Secondary | Death (Cardiac, Non-Cardiac) | 1 year | ||
Secondary | Death (Cardiac, Non-Cardiac) | 2 years | ||
Secondary | Death (Cardiac, Non-Cardiac) | 3 years | ||
Secondary | All Myocardial Infarction (All MI) | = 7 days post index procedure (In-hospital ) | ||
Secondary | All Myocardial Infarction (All MI) | 30 days | ||
Secondary | All Myocardial Infarction (All MI) | 180 days | ||
Secondary | All Myocardial Infarction (All MI) | 1 year | ||
Secondary | All Myocardial Infarction (All MI) | 2 years | ||
Secondary | All Myocardial Infarction (All MI) | 3 years | ||
Secondary | 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. | = 7 days post index procedure (In-hospital ) | |
Secondary | Target Lesion Revascularization (TLR) | 30 days | ||
Secondary | Target Lesion Revascularization (TLR) | 180 days | ||
Secondary | Target Lesion Revascularization (TLR) | 1 year | ||
Secondary | Target Lesion Revascularization (TLR) | 2 years | ||
Secondary | Target Lesion Revascularization (TLR) | 3 years | ||
Secondary | 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. | = 7 days post index procedure (In-hospital ) | |
Secondary | Ischemia Driven TLR (ID-TLR) | 30 days | ||
Secondary | Ischemia Driven TLR (ID-TLR) | 180 days | ||
Secondary | Ischemia Driven TLR (ID-TLR) | 1 year | ||
Secondary | Ischemia Driven TLR (ID-TLR) | 2 years | ||
Secondary | Ischemia Driven TLR (ID-TLR) | 3 years | ||
Secondary | 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. | = 7 days post index procedure (In-hospital ) | |
Secondary | Target Vessel Revascularization (TVR) | 30 days | ||
Secondary | Target Vessel Revascularization (TVR) | 180 days | ||
Secondary | Target Vessel Revascularization (TVR) | 1 year | ||
Secondary | Target Vessel Revascularization (TVR) | 2 years | ||
Secondary | Target Vessel Revascularization (TVR) | 3 years | ||
Secondary | All coronary revascularization | = 7 days post index procedure (In-hospital ) | ||
Secondary | All coronary revascularization | 30 days | ||
Secondary | All coronary revascularization | 180 days | ||
Secondary | All coronary revascularization | 1 year | ||
Secondary | All coronary revascularization | 2 years | ||
Secondary | All coronary revascularization | 3 years | ||
Secondary | 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 |
Acute (0 - 24 hours post stent implantation) (Definite and Probable) | |
Secondary | Scaffold thrombosis (per ARC definition) | Subacute (>24 hours - 30 days post stent implantation)(Definite and Probable) | ||
Secondary | Scaffold thrombosis (per ARC definition) | Late (30 days - 1 year post stent implantation) (Definite and Probable) | ||
Secondary | Scaffold thrombosis (per ARC definition) | Very late (>1 year post stent implantation) (Definite and Probable) | ||
Secondary | 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. | = 7 days post index procedure (In-hospital ) | |
Secondary | Death/All Myocardial Infarction (MI) | 30 days | ||
Secondary | Death/All Myocardial Infarction (MI) | 180 days | ||
Secondary | Death/All Myocardial Infarction (MI) | 1 year | ||
Secondary | Death/All Myocardial Infarction (MI) | 2 years | ||
Secondary | Death/All Myocardial Infarction (MI) | 3 years | ||
Secondary | 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. | = 7 days post index procedure (In-hospital ) | |
Secondary | Cardiac Death/All Myocardial Infarction (MI) | 30 days | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI) | 180 days | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI) | 1 year | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI) | 2 years | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI) | 3 years | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [Target vessel failure;TVF] | = 7 days post index procedure (In-hospital ) | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF] | 30 days | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF] | 180 days | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF] | 1 year | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF] | 2 years | ||
Secondary | Cardiac Death/All Myocardial Infarction (MI)/Target vessel revascularization (TVR) [TVF] | 3 years | ||
Secondary | Cardiac Death/TV MI/ID-TLR (Target lesion failure;TLF) | = 7 days post index procedure (In-hospital ) | ||
Secondary | Cardiac Death/TV MI/ID-TLR (TLF) | 30 days | ||
Secondary | Cardiac Death/TV MI/ID-TLR (TLF) | 180 days | ||
Secondary | Cardiac Death/TV MI/ID-TLR (TLF) | 1 year | ||
Secondary | Cardiac Death/TV MI/ID-TLR (TLF) | 2 years | ||
Secondary | Cardiac Death/TV MI/ID-TLR (TLF) | 3 years | ||
Secondary | Death/All Myocardial Infarction (MI)/All revascularization | = 7 days post index procedure (In-hospital ) | ||
Secondary | Death/All Myocardial Infarction (MI)/All revascularization | 30 days | ||
Secondary | Death/All Myocardial Infarction (MI)/All revascularization | 180 days | ||
Secondary | Death/All Myocardial Infarction (MI)/All revascularization | 1 year | ||
Secondary | Death/All Myocardial Infarction (MI)/All revascularization | 2 years | ||
Secondary | Death/All Myocardial Infarction (MI)/All revascularization | 3 years |
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