EverFlex Post Approval Study (DURABILITY PAS)

• 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: Medtronic Endovascular
• Information provided by (Responsible Party): Medtronic Endovascular

Tracking Information

• First Submitted Date: September 4, 2012
• First Posted Date: September 7, 2012
• Results First Submitted Date: October 23, 2019
• Results First Posted Date: December 26, 2019
• Last Update Posted Date: December 26, 2019
• Actual Study Start Date: January 14, 2013
• Actual Primary Completion Date: October 23, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 6, 2019)

Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization [ Time Frame: 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.

Original Primary Outcome Measures (submitted: September 6, 2012)

Primary Outcome - Composite endpoint [ Time Frame: 36 months ]

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.

Current Secondary Outcome Measures (submitted: December 6, 2019)

• Secondary Outcome - Freedom From Stent Fracture [ Time Frame: 1, 2 and 3 years ]
  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
• Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years [ Time Frame: 1 and 2 years ]
  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.
• Secondary Outcome - Freedom From 36-month Amputation [ Time Frame: 3 Years ]
  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.
• Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization [ Time Frame: 3 Years ]
  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.
• Secondary Outcome - Number of Participants Free From Acute Death [ Time Frame: 30 days ]
  Defined as the absence of all-cause mortality occurring within 30 days of the procedure.
• Secondary Outcome - Number of Successfully Implanted Stents [ Time Frame: At procedure ]
  Defined as the ability to deploy the stent as intended at the treatment site.
• Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year [ Time Frame: 1 Year ]
  Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.
• Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year [ Time Frame: 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.
• Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year [ Time Frame: 1 Year ]
  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
• Secondary Outcome - Number of Adverse Events [ Time Frame: 3 Years ]
  Number of Adverse Events in the study through 3 Years.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EverFlex Post Approval Study
• Official Title: The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the EverfLex NitInol STent System Post Approval Study
• Brief Summary: This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Peripheral Arterial Disease
• Lower Extremity Arterial Disease

Intervention

Device: EverFlex™ Self-Expanding Peripheral Stent System

Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.

Study Arms

Experimental: Study cohort

All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System.

Intervention: Device: EverFlex™ Self-Expanding Peripheral Stent System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2017): 108
• Original Estimated Enrollment (submitted: September 6, 2012): 169
• Actual Study Completion Date: February 4, 2019
• Actual Primary Completion Date: October 23, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

General Inclusion Criteria

1. Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts), or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries suitable for primary stenting.
2. Has a Rutherford Clinical Category Score of 2, 3 or 4.
3. Is willing to comply with all follow-up evaluations at the specified times.
4. Is ≥ to18 years old.
5. Provides written informed consent prior to enrollment in the study.

Angiographic Inclusion Criteria Subjects must meet all of the following angiographic inclusion criteria. The implanting physician bases all angiographic inclusion criteria on visual determination at the time of the procedure.

1. Target lesion(s) located within the native SFA/proximal popliteal: distal point at least 3 cm above the cortical margin of the femur and proximal point at least 1 cm below the origin of the profunda femoralis measured by straight posteroanterior (PA) view for distal lesions, ipsilateral oblique view for proximal lesions.
2. Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s).
3. Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm.
4. Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm.
5. There is evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not also require treatment for significant (> 50% stenosis or occlusion) stenosis during the index procedure.

General Exclusion Criteria

1. Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
2. Has a contraindication or known allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, contrast media or any other drug used in study according to the protocol.
3. Has known hypersensitivity to nickel-titanium.
4. Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses blood transfusion.
5. Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures.
6. Has life expectancy of less than 1 year.
7. Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during procedure.
8. Has previously been enrolled in the DURABILITY PAS study.
9. Has received endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure.
10. Has any planned surgical intervention or endovascular procedure 14 days before or 30 days after the index procedure.
11. Is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
12. Has any co-morbid condition that precludes endovascular treatment.

Angiographic Exclusion Criteria The subject must not meet any of the following angiographic exclusion criteria. The implanting physician bases all angiographic exclusion criteria on visual determination at the time of the procedure.

1. Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel lumen distal to lesion(s).
2. Presence of significant (> 50% stenosis or occlusion) ipsilateral common femoral stenosis.
3. Aneurysmal target vessel.
4. Presence of an acute intraluminal thrombus at the proposed lesion site.
5. Perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to start of PTA procedure.
6. Focal popliteal disease in the absence of femoral disease.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01680835
• Other Study ID Numbers: CP-1001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Medtronic Endovascular
• Study Sponsor: Medtronic Endovascular
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jon S Matsumura, MD; University of Wisconsin, Madison
• Principal Investigator: Krishna Rocha-Singh, MD; Prairie Heart Institute

• PRS Account: Medtronic Endovascular
• Verification Date: December 2019