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EverFlex Post Approval Study (DURABILITY PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01680835
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Peripheral Arterial Disease
Lower Extremity Arterial Disease
Intervention Device: EverFlex™ Self-Expanding Peripheral Stent System
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Cohort
Hide Arm/Group Description All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Period Title: Overall Study
Started 108
Completed 83
Not Completed 25
Arm/Group Title Study Cohort
Hide Arm/Group Description All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Baseline Participants 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants
67.06  (11.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Female
42
  38.9%
Male
66
  61.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
20
  18.5%
White
88
  81.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 108 participants
108
1.Primary Outcome
Title Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization
Hide Description 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.
Time Frame 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects experiencing primary outcome within 3 years.
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 108
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects experiencing safety composite at 1 Year
15
  13.9%
Subjects experiencing safety composite at 2 Years
23
  21.3%
Subjects experiencing safety composite at 3 Years
24
  22.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Cohort
Comments [Not Specified]
Type of Statistical Test Other
Comments Freedom from primary safety composite event at 36 months compared to a performance goal of 35%
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 0.771
Confidence Interval (1-Sided) 97.5%
0.678
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Secondary Outcome - Freedom From Stent Fracture
Hide Description

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

Time Frame 1, 2 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
There were 103 stents evaluated by the Stent Fracture Adjudication Committee.
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Stent
Stent Fracture at 1 Year 0
Stent Fracture at 2 Years 1
Stent Fracture at 3 Years 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Cohort
Comments Stent Fracture at 1 Year
Type of Statistical Test Other
Comments No hypothesis Testing for this endpoint.
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Study Cohort
Comments Stent Fracture at 2 Years
Type of Statistical Test Other
Comments No hypothesis testing was done for this endpoint.
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 0.989
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Study Cohort
Comments Stent Fracture at 3 Years
Type of Statistical Test Other
Comments No hypothesis testing was done for this endpoint
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 0.965
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years
Hide Description Defined 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.
Time Frame 1 and 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: participants
Subjects experiencing safety composite at 1 Year 15
Subjects experiencing safety composite at 2 Years 23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Cohort
Comments Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 1 year
Type of Statistical Test Other
Comments No hypothesis testing was done at this endpoint
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.034
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Study Cohort
Comments Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 2 years
Type of Statistical Test Other
Comments No hypothesis testing was done for this endpoint.
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 0.782
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Secondary Outcome - Freedom From 36-month Amputation
Hide Description Defined 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.
Time Frame 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: participants
Subjects with major amputation within 1 Year 0
Subjects with major amputation within 2 Years 1
Subjects with major amputation within 3 Years 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Cohort
Comments Estimate from freedom from major amputation through 3 years.
Type of Statistical Test Other
Comments No hypothesis testing was done for this endpoint.
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 0.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization
Hide Description Defined 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.
Time Frame 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: participants
Subjects experiencing CD-TLR within 1 Year 15
Subjects experiencing CD-TLR within 2 Years 22
Subjects experiencing CD-TLR within 3 Years 23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Cohort
Comments Freedom from clinically-driven TLR through 3 Years
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 0.781
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Secondary Outcome - Number of Participants Free From Acute Death
Hide Description Defined as the absence of all-cause mortality occurring within 30 days of the procedure.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 108
Measure Type: Count of Participants
Unit of Measure: Participants
108
 100.0%
7.Secondary Outcome
Title Secondary Outcome - Number of Successfully Implanted Stents
Hide Description Defined as the ability to deploy the stent as intended at the treatment site.
Time Frame At procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 108
Overall Number of Units Analyzed
Type of Units Analyzed: Implanted Stents
118
Count of Units
Unit of Measure: Implanted Stents
118
 100.0%
8.Secondary Outcome
Title Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year
Hide Description Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
There were 95 participants that were evaluated for the Rutherford Clinical Category at 1 Year
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 95
Measure Type: Count of Participants
Unit of Measure: Participants
88
  92.6%
9.Secondary Outcome
Title Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year
Hide Description Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
There were 71 participants that were evaluated for the Ankle-Brachial Index at 1 Year
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
62
  87.3%
10.Secondary Outcome
Title Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year
Hide Description

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

Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
The total number of participants in the study was 108; number of participants analyzed depends on the questionnaires completed
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline Score for pain aching cramp Number Analyzed 83 participants
30.42  (41.70)
Change from Baseline Walking Distance Score Number Analyzed 76 participants
28.08  (39.37)
Change from Baseline Walking Speed Score Number Analyzed 76 participants
21.77  (33.20)
Change from Baseline Stair Climbing Score Number Analyzed 75 participants
21.83  (36.05)
11.Secondary Outcome
Title Secondary Outcome - Number of Adverse Events
Hide Description Number of Adverse Events in the study through 3 Years.
Time Frame 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Cohort
Hide Arm/Group Description:
All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: Adverse Events
206
Time Frame 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Cohort
Hide Arm/Group Description All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System.
All-Cause Mortality
Study Cohort
Affected / at Risk (%)
Total   8/108 (7.41%)    
Hide Serious Adverse Events
Study Cohort
Affected / at Risk (%) # Events
Total   66/108 (61.11%)    
Blood and lymphatic system disorders   
Anaemia   5/108 (4.63%)  5
Cardiac disorders   
Acute myocardial infarction   6/108 (5.56%)  6
Angina pectoris   6/108 (5.56%)  8
Arrhythmia   3/108 (2.78%)  3
Cardio-respiratory arrest   1/108 (0.93%)  1
Coronary artery disease   3/108 (2.78%)  6
Cardiac failure congestive   5/108 (4.63%)  6
Gastrointestinal disorders   
Gastrointestinal haemorrhage   6/108 (5.56%)  6
Inguinal hernia   1/108 (0.93%)  1
Ischemic colitis   1/108 (0.93%)  1
Pancreatitis   1/108 (0.93%)  1
General disorders   
Stenosis   21/108 (19.44%)  31
Chest pain   1/108 (0.93%)  1
Death   4/108 (3.70%)  4
Gangrene   1/108 (0.93%)  1
Necrosis   1/108 (0.93%)  1
Obstruction   1/108 (0.93%)  1
Peripheral swelling   1/108 (0.93%)  1
Pyrexia   1/108 (0.93%)  1
Vascular stent thrombosis   4/108 (3.70%)  4
Infections and infestations   
Cellulitis   1/108 (0.93%)  1
Diverticulitis   1/108 (0.93%)  1
Gangrene   2/108 (1.85%)  2
Gastroenteritis   1/108 (0.93%)  1
Genital candidiasis   1/108 (0.93%)  1
Osteomyelitis   1/108 (0.93%)  1
Pneumonia   3/108 (2.78%)  8
Sepsis   1/108 (0.93%)  1
Urinary tract infection   2/108 (1.85%)  2
Vascular access site infection   1/108 (0.93%)  1
Injury, poisoning and procedural complications   
Alcohol poisoning   1/108 (0.93%)  1
Compression fracture   1/108 (0.93%)  1
Femoral neck fracture   1/108 (0.93%)  2
Hip fracture   2/108 (1.85%)  2
Restenosis   18/108 (16.67%)  19
Spinal compression fracture   1/108 (0.93%)  2
Vascular access site haematoma   3/108 (2.78%)  3
Investigations   
Liver function test increased   1/108 (0.93%)  1
Metabolism and nutrition disorders   
Dehydration   1/108 (0.93%)  1
Hypoglycemia   1/108 (0.93%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia   1/108 (0.93%)  1
Lumbar spinal stenosis   1/108 (0.93%)  1
Pain in extremity   1/108 (0.93%)  1
Rotator cuff syndrome   1/108 (0.93%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lip and/or oral cavity cancer   1/108 (0.93%)  1
Lung cancer   1/108 (0.93%)  1
Lung neoplasm malignant   2/108 (1.85%)  2
Neoplasm malignant   1/108 (0.93%)  1
Oesophageal carcinoma   1/108 (0.93%)  1
Squamous cell carcinoma   1/108 (0.93%)  1
Nervous system disorders   
Amputation stump pain   1/108 (0.93%)  1
Carotid artery disease   1/108 (0.93%)  1
Carotid artery stenosis   2/108 (1.85%)  2
Cerebrovascular accident   3/108 (2.78%)  3
Syncope   1/108 (0.93%)  1
Transient ischemic attack   1/108 (0.93%)  1
Renal and urinary disorders   
Renal failure   1/108 (0.93%)  1
Urinary retention   1/108 (0.93%)  1
Reproductive system and breast disorders   
Genital rash   1/108 (0.93%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease   2/108 (1.85%)  2
Dyspnoea   1/108 (0.93%)  1
Pneumothorax   1/108 (0.93%)  1
Respiratory symptom   1/108 (0.93%)  1
Surgical and medical procedures   
Cardiac operation   1/108 (0.93%)  1
Hernia repair   1/108 (0.93%)  1
Leg amputation   1/108 (0.93%)  1
Regional chemotherapy   1/108 (0.93%)  1
Vascular disorders   
Aortic aneurysm   1/108 (0.93%)  1
Artery dissection   5/108 (4.63%)  5
Embolism   1/108 (0.93%)  1
Hypotension   1/108 (0.93%)  1
Intermittent claudication   8/108 (7.41%)  9
Ischaemic limb pain   1/108 (0.93%)  1
Peripheral arterial occlusive disease   1/108 (0.93%)  2
Peripheral ischaemia   3/108 (2.78%)  3
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Cohort
Affected / at Risk (%) # Events
Total   0/108 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Seamans, M.S., Clinical Research Program Manager
Organization: Medtronic
Phone: 763-398-7455
EMail: jennifer.l.seamans@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01680835    
Other Study ID Numbers: CP-1001
First Submitted: September 4, 2012
First Posted: September 7, 2012
Results First Submitted: October 23, 2019
Results First Posted: December 26, 2019
Last Update Posted: December 26, 2019