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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04282148




Registration number
NCT04282148
Ethics application status
Date submitted
18/02/2020
Date registered
24/02/2020

Titles & IDs
Public title
Abbott Next Generation Drug Eluting Stent 48mm Study
Scientific title
A Clinical Investigation to Assess the Abbott Next Generation Drug Eluting Stent 48mm Everolimus Eluting Coronary Stent System (EECSS) in Treatment of de Novo Native Coronary Artery Disease
Secondary ID [1] 0 0
ABT-CIP-10321
Universal Trial Number (UTN)
Trial acronym
SPIRIT 48
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ABT NG DES 48 EECSS

Experimental: ABT NG DES 48 EECSS - Participants will receive ABT NG DES 48 EECSS device


Treatment: Devices: ABT NG DES 48 EECSS
Each participant will receive ABT NG DES 48 EECSS with appropriate diameter
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Estimate of 1-Year Target Lesion Failure (TLF)
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Number of Participants With Target Lesion Failure (TLF)
Timepoint [1] 0 0
In-hospital 6 to 12 hours post procedure
Secondary outcome [2] 0 0
Number of Participants With Target Lesion Failure (TLF)
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Number of Participants With Target Lesion Failure (TLF)
Timepoint [3] 0 0
180 days
Secondary outcome [4] 0 0
Number of Participants With Target Lesion Failure (TLF)
Timepoint [4] 0 0
1 year

Eligibility
Key inclusion criteria
General

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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/09/2023
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Taiwan
State/province [14] 0 0
North Taiwan
Country [15] 0 0
Taiwan
State/province [15] 0 0
South Taiwan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chi-Jen Chang, MD
Address 0 0
Chang Gung Memorial Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04282148