DURABILITY+ : a Prospective, Multi-center, Controlled Study With the Everflex+ Stent in SFA Lesions

NCT01412463 | Completed Phase 4 DMC

• 1 other identifier: FMRP-101208
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to evaluate the immediate and long-term (up to 12 months) safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal artery) between 40 mm and 180 mm in length.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Major Adverse Event rate

  The primary safety endpoint of the study is the Major Adverse Event (MAE) rate at 30 days. MAE is defined as: clinically-driven target lesion revascularization, amputation of treated limb or all-cause mortality through 30 days post procedure.

  30 days post-procedure

• Primary stent patency

  The primary effectiveness endpoint of the study is primary stent patency at 12 months. Primary patency is defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.

  12 months post-procedure

Secondary Outcomes (8)

• Technical success

  1 day post-procedure

• Primary stent patency at 1 and 6 months

  1 and 6 months post-procedure

• Primary assisted patency

  1, 6 and 12 months post-procedure

• Secondary patency

  1, 6 and 12 months post-procedure

• Target lesion revascularization

  12 months post-procedure

Study Arms (1)

Protégé EverFlex+

EXPERIMENTAL

Stenting with Protégé EverFlex+

Device: stent placement

Interventions

stent placement DEVICE

* pre-dilation of the study lesion is mandatory * stent placement with 1 Protégé Everflex+ stent * only 1 stent is allowed within the study protocol * post-dilation may be performed but is not mandatory

Also known as: Protégé EverFlex+

Protégé EverFlex+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• De novo, restenotic or reoccluded (from PTA or adjunct therapy, not including stents or stent grafts) lesion located in the superficial femoral artery (without popliteal involvement) with proximal point at least one centimeter below the origin of the profunda femoralis and suitable for stenting
• Patient presenting with a score from 2 to 4 following Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is \>18 years old
• Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
• The length of the target lesion is minimally 40 mm and maximally 180 mm, to be covered with one stent
• The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
• Target vessel diameter visually estimated is \>3.5 mm and \<7.5 mm
• Prior to enrollment, the guidewire has crossed target lesion
• There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention
• Patient is eligible for treatment with the Protégé Everflex+ stent system

You may not qualify if:

• Presence of another stent or stent graft in the target vessel that was placed during a previous procedure
• Previous by-pass surgery in the same limb requiring access to the target lesion
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated or no alternative is available
• Patients with known hypersensitivity to nickel-titanium
• Patients with uncorrected bleeding disorders
• Female patient with child bearing potential not using adequate contraceptives or currently breastfeeding
• Life expectancy of less than twelve months
• Use of thrombectomy, artherectomy, cryoplasty, cutting balloon, drug-eluting balloon, embolic protection or laser devices during procedure
• Any patient considered to be hemodynamically unstable at onset of procedure
• Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
• Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
• Patients who exhibit persistent acute intraluminal thrombus of the proposed target lesion site
• Perforation, dissection or other injury of the access site or target vessel requiring additional stenting or surgical intervention prior to start of the index procedure
• Perforation at the angioplasty site evidenced by extravasation of contrast medium
• Aneurysm located at the level of the SFA and/or proximal popliteal

Sponsors & Collaborators

• Flanders Medical Research Program: lead
• Medtronic Neurovascular Clinical Affairs: collaborator

Study Sites (3)

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

Location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, East-Flanders, 9200, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

BE (3)