Trial Outcomes & Findings for EverFlex Post Approval Study (NCT NCT01680835)
NCT ID: NCT01680835
Last Updated: 2019-12-26
Results Overview
Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
3 Years
Results posted on
2019-12-26
Participant Flow
Participant milestones
| Measure |
Study Cohort
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EverFlex Post Approval Study
Baseline characteristics by cohort
| Measure |
Study Cohort
n=108 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Age, Continuous
|
67.06 years
STANDARD_DEVIATION 11.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 YearsPopulation: Subjects experiencing primary outcome within 3 years.
Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.
Outcome measures
| Measure |
Study Cohort
n=108 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
Subjects experiencing safety composite at 2 Years
|
23 Participants
|
|
Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
Subjects experiencing safety composite at 1 Year
|
15 Participants
|
|
Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
Subjects experiencing safety composite at 3 Years
|
24 Participants
|
SECONDARY outcome
Timeframe: 1, 2 and 3 yearsPopulation: There were 103 stents evaluated by the Stent Fracture Adjudication Committee.
Determined by x-ray at 1, 2 and 3 years using the following classifications: Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration AND the following categories: Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine
Outcome measures
| Measure |
Study Cohort
n=103 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Freedom From Stent Fracture
Stent Fracture at 1 Year
|
0 Stent
|
|
Secondary Outcome - Freedom From Stent Fracture
Stent Fracture at 2 Years
|
1 Stent
|
|
Secondary Outcome - Freedom From Stent Fracture
Stent Fracture at 3 Years
|
3 Stent
|
SECONDARY outcome
Timeframe: 1 and 2 yearsDefined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.
Outcome measures
| Measure |
Study Cohort
n=108 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years
Subjects experiencing safety composite at 1 Year
|
15 participants
|
|
Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years
Subjects experiencing safety composite at 2 Years
|
23 participants
|
SECONDARY outcome
Timeframe: 3 YearsDefined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.
Outcome measures
| Measure |
Study Cohort
n=108 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Freedom From 36-month Amputation
Subjects with major amputation within 1 Year
|
0 participants
|
|
Secondary Outcome - Freedom From 36-month Amputation
Subjects with major amputation within 2 Years
|
1 participants
|
|
Secondary Outcome - Freedom From 36-month Amputation
Subjects with major amputation within 3 Years
|
1 participants
|
SECONDARY outcome
Timeframe: 3 YearsDefined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.
Outcome measures
| Measure |
Study Cohort
n=108 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization
Subjects experiencing CD-TLR within 1 Year
|
15 participants
|
|
Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization
Subjects experiencing CD-TLR within 2 Years
|
22 participants
|
|
Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization
Subjects experiencing CD-TLR within 3 Years
|
23 participants
|
SECONDARY outcome
Timeframe: 30 daysDefined as the absence of all-cause mortality occurring within 30 days of the procedure.
Outcome measures
| Measure |
Study Cohort
n=108 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Number of Participants Free From Acute Death
|
108 Participants
|
SECONDARY outcome
Timeframe: At procedureDefined as the ability to deploy the stent as intended at the treatment site.
Outcome measures
| Measure |
Study Cohort
n=118 Implanted Stents
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Number of Successfully Implanted Stents
|
118 Implanted Stents
|
SECONDARY outcome
Timeframe: 1 YearPopulation: There were 95 participants that were evaluated for the Rutherford Clinical Category at 1 Year
Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.
Outcome measures
| Measure |
Study Cohort
n=95 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year
|
88 Participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: There were 71 participants that were evaluated for the Ankle-Brachial Index at 1 Year
Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI \< 0.9.
Outcome measures
| Measure |
Study Cohort
n=71 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year
|
62 Participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: The total number of participants in the study was 108; number of participants analyzed depends on the questionnaires completed
Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes
Outcome measures
| Measure |
Study Cohort
n=108 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year
Change from Baseline Walking Distance Score
|
28.08 score on a scale
Standard Deviation 39.37
|
|
Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year
Change from Baseline Score for pain aching cramp
|
30.42 score on a scale
Standard Deviation 41.70
|
|
Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year
Change from Baseline Walking Speed Score
|
21.77 score on a scale
Standard Deviation 33.20
|
|
Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year
Change from Baseline Stair Climbing Score
|
21.83 score on a scale
Standard Deviation 36.05
|
SECONDARY outcome
Timeframe: 3 YearsNumber of Adverse Events in the study through 3 Years.
Outcome measures
| Measure |
Study Cohort
n=108 Participants
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
Secondary Outcome - Number of Adverse Events
|
206 Adverse Events
|
Adverse Events
Study Cohort
Serious events: 66 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Study Cohort
n=108 participants at risk
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
|
|---|---|
|
General disorders
Stenosis
|
19.4%
21/108 • Number of events 31 • 36 months
|
|
Blood and lymphatic system disorders
Anaemia
|
4.6%
5/108 • Number of events 5 • 36 months
|
|
Cardiac disorders
Acute myocardial infarction
|
5.6%
6/108 • Number of events 6 • 36 months
|
|
Cardiac disorders
Angina pectoris
|
5.6%
6/108 • Number of events 8 • 36 months
|
|
Cardiac disorders
Arrhythmia
|
2.8%
3/108 • Number of events 3 • 36 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Cardiac disorders
Coronary artery disease
|
2.8%
3/108 • Number of events 6 • 36 months
|
|
Cardiac disorders
Cardiac failure congestive
|
4.6%
5/108 • Number of events 6 • 36 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.6%
6/108 • Number of events 6 • 36 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Ischemic colitis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Chest pain
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Death
|
3.7%
4/108 • Number of events 4 • 36 months
|
|
General disorders
Gangrene
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Necrosis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Obstruction
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Peripheral swelling
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Pyrexia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
General disorders
Vascular stent thrombosis
|
3.7%
4/108 • Number of events 4 • 36 months
|
|
Infections and infestations
Cellulitis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Diverticulitis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Gangrene
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Infections and infestations
Gastroenteritis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Genital candidiasis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Osteomyelitis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Pneumonia
|
2.8%
3/108 • Number of events 8 • 36 months
|
|
Infections and infestations
Sepsis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Infections and infestations
Vascular access site infection
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Injury, poisoning and procedural complications
Restenosis
|
16.7%
18/108 • Number of events 19 • 36 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
2.8%
3/108 • Number of events 3 • 36 months
|
|
Investigations
Liver function test increased
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Amputation stump pain
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Carotid artery disease
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Carotid artery stenosis
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Nervous system disorders
Cerebrovascular accident
|
2.8%
3/108 • Number of events 3 • 36 months
|
|
Nervous system disorders
Syncope
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Nervous system disorders
Transient ischemic attack
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Renal failure
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Renal and urinary disorders
Urinary retention
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Reproductive system and breast disorders
Genital rash
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.9%
2/108 • Number of events 2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Cardiac operation
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Hernia repair
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Leg amputation
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Surgical and medical procedures
Regional chemotherapy
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Aortic aneurysm
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Artery dissection
|
4.6%
5/108 • Number of events 5 • 36 months
|
|
Vascular disorders
Embolism
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Hypotension
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Intermittent claudication
|
7.4%
8/108 • Number of events 9 • 36 months
|
|
Vascular disorders
Ischaemic limb pain
|
0.93%
1/108 • Number of events 1 • 36 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.93%
1/108 • Number of events 2 • 36 months
|
|
Vascular disorders
Peripheral ischaemia
|
2.8%
3/108 • Number of events 3 • 36 months
|
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Seamans, M.S., Clinical Research Program Manager
Medtronic
Phone: 763-398-7455
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place