Coronary Artery Disease
Conditions
Keywords
De novo native coronary artery long lesions, ABT NG DES 48 EECSS, ABT-CIP-10321, Coronary artery luminal diameter, SPIRIT 48
Brief summary
The purpose of this SPIRIT 48 study is to evaluate the safety and effectiveness of the ABT NG DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease (CAD) due to de novo native coronary artery long lesions.
Detailed description
The SPIRIT 48 mm study is a prospective, single arm, open-label, multi-center global (US and outside of US) clinical investigation to evaluate the safety and effectiveness of the ABT Next Generation Drug Eluting Stent 48 mm everolimus-eluting coronary stent system (EECSS) (called ABT NG DES 48) in up to 107 subjects at up to 33 sites globally. The clinical outcomes from the SPIRIT 48 study will be compared to a performance goal (PG) established using historical control data from the SPIRIT Prime Long Lesion Registry. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the ABT NG DES 48 in the United States.
Interventions
DEVICEABT NG DES 48 EECSS
Each participant will receive ABT NG DES 48 EECSS with appropriate diameter
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, global (US and OUS)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements. 3. Subject must have evidence of myocardial ischemia (e.g., unstable angina, post-infarct angina, stable angina or silent ischemia) suitable for non-emergent PCI. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following, * Abnormal stress or imaging stress test * Abnormal computed tomography-fractional flow reserve (CT-FFR) * Stenosis by visual estimation ≥ 70% * Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio \[iFR\], or relative flow reserve \[RFR\]) 4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. 5. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria: 1. Only one de novo target lesion in native coronary artery is allowed to be treated with the investigational stent. • One additional non-target lesion can be treated if it is located in a different epicardial coronary vessel and NOT in left main coronary artery. The non-target lesion must be treated first and must be deemed an angiographic success. 2. The target lesion must be located in a native coronary artery with: * Visually estimated reference vessel diameter (RVD) of ≥ 2.5 mm and ≤ 4.25 mm. * Visually estimated lesion length of \> 32 mm and ≤ 44 mm, and able to be covered by a single ABT NG DES 48. a. Multiple focal de novo lesions in an epicardial coronary vessel are allowed if the lesions can be covered by one stent. Multiple focal de novo lesions will be counted as a single lesion. * Visually estimated diameter stenosis of \> 50% and \< 100% with a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ 1 1. Stable angina or silent ischemia subjects must have stenosis ≥ 70%, or abnormal pressure-derived physiological indices (FFR, iFR, or RFR), unless abnormal stress or imaging stress test is evidenced. General
Exclusion criteria
1. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers, etc.), or has known contrast sensitivity. 2. Subject has known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel /prasugrel /ticagrelor), and therefore cannot be adequately pre-medicated. 3. Subject has a planned surgery or procedure necessitating discontinuation of aspirin or P2Y12 inhibitor within 12 months following index procedure. 4. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason). 5. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. 6. Subject had an acute myocardial infarction (AMI) within 48 hours of the index procedure with either of the situations below: * The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic electrocardiogram (ECG) changes * Elevated cardiac biomarker values have not returned to within normal limits at the time of index procedure. 7. Subject has a left ventricular ejection fraction (LVEF) \< 30% within 3 months prior to the index procedure, that was documented by any method. 8. Subject is expected to require percutaneous mechanical cardiac support at the index procedure. 9. Prior PCI within the target vessel during the last 12 months prior to consent. 10. Prior PCI within the non-target vessel or any peripheral intervention during the last 30 days prior to consent. 11. At the index procedure, subject is identified to require planned stenting procedure (including staged procedures) or CABG after the index procedure. 12. Subject has received a solid organ transplant which is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months. 13. Subject has a malignancy that is not in remission. 14. Subject is receiving immunosuppressant therapy or has known life-threatening immunosuppressive or severe autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease 15. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum. 16. Subject has a platelet count \< 100,000 cells/mm\^3 or \> 700,000 cells/mm\^3. 17. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73m\^2 or dialysis at the time of consent. 18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months. 19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past 6 months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.). 20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the subject if radial access may be used. 21. Subject has life expectancy \< 2 years. 22. Subject is, in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Subject Reported Outcome instruments. 23. Subject is currently participating in another clinical investigation (except for non-invasive observational studies) that has not yet completed its primary endpoint. 24. Subject intends to participate in another investigational drug or device clinical investigation (except for non-invasive observational studies) within 12 months after the index procedure. 25. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy less than 2 years. 26. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 27. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimate of 1-Year Target Lesion Failure (TLF) | 1 year | Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Lesion Failure (TLF) | In-hospital 6 to 12 hours post procedure | Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\]) |
Countries
Australia, Taiwan, United States
Participant flow
Recruitment details
A total of 107 subjects were registered at 25 study sites globally. Of the 107 registered subjects, the study device was successfully implanted in 105 subjects and 2 subjects were excluded from analyses as they did not receive the study device implanted. The study registered the first subject on June 17, 2020, and the last subject on September 17, 2021. The last 1-year follow-up visit occurred on October 7, 2022. The last 2-year follow-up visit occurred on September 18, 2023.
Pre-assignment details
One subject expired during the 2-year-follow up window and is showing as completed under overall study status.
Participants by arm
| Arm | Count |
|---|---|
| ABT NG DES 48 EECSS Participants will receive ABT NG DES 48 EECSS device
ABT NG DES 48 EECSS: Each participant will receive ABT NG DES 48 EECSS with appropriate diameter | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | ABT NG DES 48 EECSS |
|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 10.8 |
| Dyslipidemia | 93 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Hypertension | 87 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 38 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 105 |
| other Total, other adverse events | 49 / 105 |
| serious Total, serious adverse events | 42 / 105 |
Outcome results
Primary
Kaplan-Meier Estimate of 1-Year Target Lesion Failure (TLF)
Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\])
Time frame: 1 year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT NG DES 48 EECSS | Kaplan-Meier Estimate of 1-Year Target Lesion Failure (TLF) | 5.7 Percentage of events |
p-value: <0.0001Z test using Kaplan Meier survival estim
Secondary
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\])
Time frame: In-hospital 6 to 12 hours post procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per SCAI definition | 4 participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per ARC 2 definition | 5 participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per 4th Universal definition | 3 participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\])
Time frame: 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per 4th Universal definition | 4 participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per SCAI definition | 5 participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per ARC 2 definition | 6 participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\])
Time frame: 180 days
Population: Subjects who were truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR events (all death, all MI regardless of MI definition, all revascularization), were removed from the TLF analysis at specific time point. One subject withdrew from the study prior to 6 month (180 days) post procedure. Subject number analyzed at 180 days time frame went down from 105 to 104.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per SCAI definition | 5 participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per ARC 2 definition | 6 participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per 4th Universal definition | 4 participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\])
Time frame: 1 year
Population: Subjects who are terminated through a given time point without any DMR events were removed from TLF analysis at specific time point.~One subject withdrew from the study prior to 6 month (180 days) post procedure, the subject number analyzed went down from 105 to 104.~At 391 days after enrollment (within 1 year follow up window), one subject withdrew from the study, the subject was included in TLF analysis at 1 year, subject number analyzed at 1 year time frame stayed at 104.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per SCAI definition | 6 participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per ARC 2 definition | 7 participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per 4th Universal definition | 5 participants |
Secondary
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\]).
Time frame: 2 year
Population: Subjects who are terminated through a given time point without any DMR events were removed from TLF analysis at specific time point.~1 subject withdrew from the study prior to 6 month (180 days) post procedure, subject number went down from 105 to 104.~At 391 days after enrollment (within 1 year follow up window), one subject withdrew from the study was included in TLF analysis at 1 year and excluded from 2 year time frame, hence number analyzed at 2 year time frame went down from 104 to 103.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per SCAI definition | 9 Participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per ARC 2 definition | 10 Participants |
| ABT NG DES 48 EECSS | Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure per 4th Universal definition | 8 Participants |