Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
107 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-06-17
Study Completion Date
2023-09-17
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Coronary Artery Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Prospective, multi-center, global (US and OUS)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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ABT NG DES 48 EECSS
Participants will receive ABT NG DES 48 EECSS device
Group Type
EXPERIMENTAL
ABT NG DES 48 EECSS
Intervention Type
DEVICE
Each participant will receive ABT NG DES 48 EECSS with appropriate diameter
Interventions
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ABT NG DES 48 EECSS
Each participant will receive ABT NG DES 48 EECSS with appropriate diameter
Intervention Type
DEVICE
Eligibility Criteria
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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.
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.
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.
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.
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.
1. Target lesion/vessel meets any of the following criteria:
* Prevents complete angioplasty balloon (plain old balloon angioplasty \[POBA\], scoring balloon, or cutting balloon) inflation, such as:
* Heavy calcified lesion
* Requires additional device for lesion preparation (e.g. rotablator or laser).
* Anatomy proximal to or within the lesion that prevents proper placement of delivery system:
* Extreme angulation (≥ 90°) proximal to or within the target lesion.
* Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
* Involves a bifurcation of which the side branch will be jailed by the struts and requiring side branch pre-dilatation by Kissing Balloon Technique, and/or stenting
* Is located:
* In left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the left anterior descending coronary artery \[LAD\] and/or left circumflex coronary artery \[LCX\] arteries is present), and there is no intention to treat the protected left main lesion.
* Within 3 mm of the origin of the LAD or LCX.
* Within 3 mm of aorto-ostial right coronary artery (RCA).
* In a bypass graft or distal to anastomotic site of bypass graft.
* With total occlusion (TIMI flow 0), prior to crossing with the wire.
* Contains thrombus
* The subject has been previously treated with a stent within 1-year prior to the index procedure such that the ABT NG DES 48 would need to cross the stent to reach the target lesion.
2. Unsuccessful target lesion pre-dilatation, defined as the presence of one or more of the following:
* Failed for a full inflation of the pre-dilatation balloon.
* TIMI flow grade \<3 (per visual estimation).
* Any angiographic complication (e.g. distal embolization, no-reflow)
* Any dissection National Heart, Lung, and Blood Institute (NHLBI) grade D-F.
* Any chest pain lasting \> 5 minutes.
* Any ST-segment depression or elevation lasting \> 5 minutes.
* Side branch requires additional dilatation/stenting caused by plaque shift, carina shift or may require additional dilatation/stenting after stent implantation, per the operator's assessment.
3. Non-target lesion meets any of the following criteria:
* Is located in the target vessel
* Is located in the left main location
* Is restenotic from a previous stent implantation
* Is located within a saphenous vein graft or an arterial graft
* Is with a TIMI flow 0 (total occlusion) prior to guide wire crossing
* Involves a complex bifurcation that needs two-stent strategy.
4. Treatment of non-target lesion is not deemed successful.
Note: A successful treatment is defined as a treatment resulted in a mean lesion diameter stenosis \< 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
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.
1. Target lesion/vessel meets any of the following criteria:
* Prevents complete angioplasty balloon (plain old balloon angioplasty \[POBA\], scoring balloon, or cutting balloon) inflation, such as:
* Heavy calcified lesion
* Requires additional device for lesion preparation (e.g. rotablator or laser).
* Anatomy proximal to or within the lesion that prevents proper placement of delivery system:
* Extreme angulation (≥ 90°) proximal to or within the target lesion.
* Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
* Involves a bifurcation of which the side branch will be jailed by the struts and requiring side branch pre-dilatation by Kissing Balloon Technique, and/or stenting
* Is located:
* In left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the left anterior descending coronary artery \[LAD\] and/or left circumflex coronary artery \[LCX\] arteries is present), and there is no intention to treat the protected left main lesion.
* Within 3 mm of the origin of the LAD or LCX.
* Within 3 mm of aorto-ostial right coronary artery (RCA).
* In a bypass graft or distal to anastomotic site of bypass graft.
* With total occlusion (TIMI flow 0), prior to crossing with the wire.
* Contains thrombus
* The subject has been previously treated with a stent within 1-year prior to the index procedure such that the ABT NG DES 48 would need to cross the stent to reach the target lesion.
2. Unsuccessful target lesion pre-dilatation, defined as the presence of one or more of the following:
* Failed for a full inflation of the pre-dilatation balloon.
* TIMI flow grade \<3 (per visual estimation).
* Any angiographic complication (e.g. distal embolization, no-reflow)
* Any dissection National Heart, Lung, and Blood Institute (NHLBI) grade D-F.
* Any chest pain lasting \> 5 minutes.
* Any ST-segment depression or elevation lasting \> 5 minutes.
* Side branch requires additional dilatation/stenting caused by plaque shift, carina shift or may require additional dilatation/stenting after stent implantation, per the operator's assessment.
3. Non-target lesion meets any of the following criteria:
* Is located in the target vessel
* Is located in the left main location
* Is restenotic from a previous stent implantation
* Is located within a saphenous vein graft or an arterial graft
* Is with a TIMI flow 0 (total occlusion) prior to guide wire crossing
* Involves a complex bifurcation that needs two-stent strategy.
4. Treatment of non-target lesion is not deemed successful.
Note: A successful treatment is defined as a treatment resulted in a mean lesion diameter stenosis \< 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Chi-Jen Chang, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Ki E Park, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida/Malcom Randall VAMC
Locations
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HonorHealth
Scottsdale, Arizona, United States
Site Status
Scripps Memorial Hospital - La Jolla
La Jolla, California, United States
Site Status
UCLA Medical Center Santa Monica
Santa Monica, California, United States
Site Status
The Cardiac & Vascular Institute Research Foundation, LLC
Gainesville, Florida, United States
Site Status
Shands at the University of Florida
Gainesville, Florida, United States
Site Status
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States
Site Status
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Site Status
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Site Status
North Mississippi Medical Center
Tupelo, Mississippi, United States
Site Status
St. Patrick Hospital
Missoula, Montana, United States
Site Status
Mount Sinai Hospital
New York, New York, United States
Site Status
The Lindner Center
Cincinnati, Ohio, United States
Site Status
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Site Status
Pinnacle Health System
Harrisburg, Pennsylvania, United States
Site Status
Greenville Health System
Greenville, South Carolina, United States
Site Status
Baylor Scott & White Heart & Vascular Hospital
Dallas, Texas, United States
Site Status
The Heart Hospital Baylor Plano
Plano, Texas, United States
Site Status
Liverpool Hospital
Liverpool, New South Wales, Australia
Site Status
The Prince Charles Hospital
Chermside, Queensland, Australia
Site Status
Royal North Shore Hospital
St Leonards, , Australia
Site Status
Chang Gung Memorial Hospital
Linkou District, North Taiwan, Taiwan
Site Status
National Taiwan University Hospital
Taipei, North Taiwan, Taiwan
Site Status
Cheng Hsin General Hospital
Taipei, North Taiwan, Taiwan
Site Status
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, South Taiwan, Taiwan
Site Status
Countries
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United States
Australia
Taiwan
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABT-CIP-10321
Identifier Type: -
Identifier Source: org_study_id
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