Trial Outcomes & Findings for Abbott Next Generation Drug Eluting Stent 48mm Study (NCT NCT04282148)
NCT ID: NCT04282148
Last Updated: 2025-01-08
Results Overview
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 \[CI-TLR\])
COMPLETED
NA
107 participants
1 year
2025-01-08
Participant Flow
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.
One subject expired during the 2-year-follow up window and is showing as "completed" under overall study status.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Abbott Next Generation Drug Eluting Stent 48mm Study
Baseline characteristics by cohort
| Measure |
ABT NG DES 48 EECSS
n=105 Participants
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
|
|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Hypertension
|
87 Participants
n=5 Participants
|
|
Dyslipidemia
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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 \[CI-TLR\])
Outcome measures
| Measure |
ABT NG DES 48 EECSS
n=105 Participants
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
|
|---|---|
|
Kaplan-Meier Estimate of 1-Year Target Lesion Failure (TLF)
|
5.7 Percentage of events
|
SECONDARY outcome
Timeframe: In-hospital 6 to 12 hours post procedurePopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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 \[CI-TLR\])
Outcome measures
| Measure |
ABT NG DES 48 EECSS
n=105 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per SCAI definition
|
4 participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per ARC 2 definition
|
5 participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per 4th Universal definition
|
3 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: The number of participants analyzed includes subjects who had available follow up data at that time frame.
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 \[CI-TLR\])
Outcome measures
| Measure |
ABT NG DES 48 EECSS
n=105 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per SCAI definition
|
5 participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per ARC 2 definition
|
6 participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per 4th Universal definition
|
4 participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: 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.
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 \[CI-TLR\])
Outcome measures
| Measure |
ABT NG DES 48 EECSS
n=104 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per SCAI definition
|
5 participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per ARC 2 definition
|
6 participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per 4th Universal definition
|
4 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
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 \[CI-TLR\])
Outcome measures
| Measure |
ABT NG DES 48 EECSS
n=104 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per SCAI definition
|
6 participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per ARC 2 definition
|
7 participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per 4th Universal definition
|
5 participants
|
SECONDARY outcome
Timeframe: 2 yearPopulation: 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.
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 \[CI-TLR\]).
Outcome measures
| Measure |
ABT NG DES 48 EECSS
n=103 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per SCAI definition
|
9 Participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per ARC 2 definition
|
10 Participants
|
|
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure per 4th Universal definition
|
8 Participants
|
Adverse Events
ABT NG DES 48 EECSS
Serious adverse events
| Measure |
ABT NG DES 48 EECSS
n=105 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.95%
1/105 • 2 Year
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.95%
1/105 • 2 Year
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.95%
1/105 • 2 Year
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.95%
1/105 • 2 Year
|
|
Cardiac disorders
ANGINA PECTORIS
|
7.6%
8/105 • 2 Year
|
|
Cardiac disorders
ARRHYTHMIA
|
4.8%
5/105 • 2 Year
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.95%
1/105 • 2 Year
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
6.7%
7/105 • 2 Year
|
|
Cardiac disorders
CORONARY ARTERY DISSECTION
|
1.9%
2/105 • 2 Year
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.9%
2/105 • 2 Year
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.95%
1/105 • 2 Year
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.95%
1/105 • 2 Year
|
|
General disorders
CHEST PAIN
|
0.95%
1/105 • 2 Year
|
|
General disorders
OEDEMA PERIPHERAL
|
0.95%
1/105 • 2 Year
|
|
Infections and infestations
CORONA VIRUS INFECTION
|
0.95%
1/105 • 2 Year
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.95%
1/105 • 2 Year
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.95%
1/105 • 2 Year
|
|
Injury, poisoning and procedural complications
PLAQUE SHIFT
|
0.95%
1/105 • 2 Year
|
|
Investigations
COLONOSCOPY
|
0.95%
1/105 • 2 Year
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
1.9%
2/105 • 2 Year
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.95%
1/105 • 2 Year
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.95%
1/105 • 2 Year
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.95%
1/105 • 2 Year
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
2.9%
3/105 • 2 Year
|
|
Nervous system disorders
DYSTONIA
|
0.95%
1/105 • 2 Year
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.95%
1/105 • 2 Year
|
|
Renal and urinary disorders
RENAL FAILURE
|
2.9%
3/105 • 2 Year
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.95%
1/105 • 2 Year
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
2.9%
3/105 • 2 Year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.95%
1/105 • 2 Year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.95%
1/105 • 2 Year
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.95%
1/105 • 2 Year
|
|
Vascular disorders
HAEMORRHAGE
|
3.8%
4/105 • 2 Year
|
|
Vascular disorders
HYPOTENSION
|
2.9%
3/105 • 2 Year
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.95%
1/105 • 2 Year
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.95%
1/105 • 2 Year
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.95%
1/105 • 2 Year
|
|
General disorders
ASTHENIA
|
0.95%
1/105 • 2 Year
|
|
General disorders
DEATH
|
3.8%
4/105 • 2 Year
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.95%
1/105 • 2 Year
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.95%
1/105 • 2 Year
|
|
Infections and infestations
PNEUMONIA
|
1.9%
2/105 • 2 Year
|
|
Infections and infestations
SEPSIS
|
1.9%
2/105 • 2 Year
|
|
Investigations
BLOOD CULTURE POSITIVE
|
0.95%
1/105 • 2 Year
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.95%
1/105 • 2 Year
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.95%
1/105 • 2 Year
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.95%
1/105 • 2 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.95%
1/105 • 2 Year
|
|
Nervous system disorders
COMA
|
0.95%
1/105 • 2 Year
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.95%
1/105 • 2 Year
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.95%
1/105 • 2 Year
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.95%
1/105 • 2 Year
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.95%
1/105 • 2 Year
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.9%
2/105 • 2 Year
|
|
Surgical and medical procedures
FINGER AMPUTATION
|
0.95%
1/105 • 2 Year
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.95%
1/105 • 2 Year
|
Other adverse events
| Measure |
ABT NG DES 48 EECSS
n=105 participants at risk
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
|
|---|---|
|
General disorders
NON-CARDIAC CHEST PAIN
|
8.6%
9/105 • 2 Year
|
|
Investigations
CARDIAC ENZYMES INCREASED
|
36.2%
38/105 • 2 Year
|
|
Infections and infestations
CORONA VIRUS INFECTION
|
7.6%
8/105 • 2 Year
|
|
Nervous system disorders
DIZZINESS
|
5.7%
6/105 • 2 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60