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

Peripheral Vascular Diseases Clinical Trial

— DURABILITY II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530712
• Other study ID #: P-2424
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: July 2013

Study information

• Verified date: February 2019
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: July 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

References & Publications (1)

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 Proté — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency	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.	1 Year
Primary	Major Adverse Events	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)	30 Days
Secondary	Single-Stent Primary Patency	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.	1 Year
Secondary	Single-Stent Major Adverse Events	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.	30 Days
Secondary	Major Adverse Events	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.	1 Year
Secondary	Stent Fracture Rate	Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation.	1, 2 and 3 Years
Secondary	Number of Participants With Decline in Rutherford Clinical Category	Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss.	30 days
Secondary	Improvement in Rutherford Clinical Category	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.	1 year
Secondary	Increase in Ankle-Brachial Index From Baseline to 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.	1 Year
Secondary	Assisted Primary Patency	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.	1 Year
Secondary	Secondary Patency	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.	1 Year
Secondary	Absolute Claudication Distance Improvement	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.	1 Year
Secondary	Walking Improvement	Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline.	1 Year
Secondary	Duplex Ultrasound = 2.4 Primary Patency	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.	1 Year