Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis - Full Text View

Purpose

This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.

Condition	Intervention	Phase
Peripheral Vascular Diseases Claudication	Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II

Resource links provided by NLM:

Drug Information available for: Menthol

U.S. FDA Resources

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:

Primary Patency [ Time Frame: 1 Year ]
Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.
Major Adverse Events [ Time Frame: 30 Days ]
Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)

Secondary Outcome Measures:

Single-Stent Primary Patency [ Time Frame: 1 Year ]
Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.
Single-Stent Major Adverse Events [ Time Frame: 30 Days ]
MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.
Major Adverse Events [ Time Frame: 1 Year ]
MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.
Stent Fracture Rate [ Time Frame: 1, 2 and 3 Years ]
Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. only 1 year data presented here.
Decline in Rutherford Clinical Category [ Time Frame: 30 Days ]
Defined as an increase of one or more categories in RCC compared to baseline.
Improvement in Rutherford Clinical Category [ Time Frame: 1 Year ]
Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.
Increase in Ankle-Brachial Index [ Time Frame: 1 Year ]
Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.
Assisted Primary Patency [ Time Frame: 1 Year ]
Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.
Secondary Patency [ Time Frame: 1 Year ]
Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.
Absolute Claudication Distance Improvement [ Time Frame: 1 Year ]
Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.
Walking Improvement [ Time Frame: 1 Year ]
Duplex Ultrasound ≤ 2.4 Primary Patency [ Time Frame: 1 Year ]
Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.


Enrollment:	287
Study Start Date:	August 2007
Study Completion Date:	July 2013
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PTA and Stenting with EverFlex device Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System	Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Symptomatic femoral-popliteal atherosclerosis.
Willing to comply with all follow-up evaluations at the specified times.
Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

Previously implanted stent(s) or stent graft(s) in the target vessel.
Planned use of devices other than angioplasty balloons during procedure.
Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
Life expectancy of less than 12 months.
Symptomatic femoral disease in the opposite limb.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530712

Sponsors and Collaborators

Medtronic Endovascular

Investigators


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

More Information

Publications:

Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013 Jul;58(1):73-83.e1. doi: 10.1016/j.jvs.2012.12.066. Epub 2013 May 2.


Responsible Party:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT00530712 History of Changes
Other Study ID Numbers:	P-2424
Study First Received:	September 14, 2007
Results First Received:	July 28, 2014
Last Updated:	August 14, 2015

Keywords provided by Medtronic Endovascular:


SFA Popliteal Stent EverFlex

Additional relevant MeSH terms:


Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases Atherosclerosis	Arteriosclerosis Arterial Occlusive Diseases Menthol Antipruritics Dermatologic Agents

ClinicalTrials.gov processed this record on June 26, 2017

Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II)