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

This study has been completed.
Sponsor:
Collaborator:
ev3
Information provided by (Responsible Party):
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT01412463
First received: August 8, 2011
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Device: stent placement
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DURABILITY+ : a Prospective, Multi-center, Controlled Study Measuring the Durability in Lesions of the Superficial Femoral Artery of the Protégé Everflex+ Stent

Resource links provided by NLM:


Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • Major Adverse Event rate [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]
    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.

  • Primary stent patency [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Technical success [ Time Frame: 1 day post-procedure ] [ Designated as safety issue: No ]
    Technical success, defined as the ability to cross and stent the lesion, after predilation, and with or without additional post-dilation, and achieve residual angiographic stenosis no greater than 30%

  • Primary stent patency at 1 and 6 months [ Time Frame: 1 and 6 months post-procedure ] [ Designated as safety issue: No ]
    Primary patency at 1, 6 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 the time of procedure and the given follow-up.

  • Primary assisted patency [ Time Frame: 1, 6 and 12 months post-procedure ] [ Designated as safety issue: No ]
    Primary assisted patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.

  • Secondary patency [ Time Frame: 1, 6 and 12 months post-procedure ] [ Designated as safety issue: No ]
    Secondary patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.

  • Target lesion revascularization [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: No ]
    Target lesion revascularization (TLR) is defined as a repeat intervention, within the study follow-up period of 12 months, to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.

  • limb-salvage [ Time Frame: 12-months post-procedure ] [ Designated as safety issue: No ]
    Limb-salvage rate at all follow-up visits for the subgroup of patients with critical limb ischemia (Rutherford category 4), defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot)

  • Clinical success [ Time Frame: 1, 6 and 12 months post-procedure ] [ Designated as safety issue: No ]
    Clinical success at follow-up, defined as an improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification

  • Serious adverse events [ Time Frame: 12-months post-procedure ] [ Designated as safety issue: No ]
    Serious adverse events defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.


Enrollment: 60
Study Start Date: May 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protégé EverFlex+
Stenting with Protégé EverFlex+
Device: stent placement
  • 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
Other Name: Protégé EverFlex+

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  • 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

Angiographic Inclusion Criteria

  • 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

General Exclusion Criteria:

  • 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.

Angiographic Exclusion Criteria

  • 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
  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: NCT01412463

Locations
Belgium
Imelda Hospital
Bonheiden, Antwerp, Belgium, 2820
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
A.Z. Sint-Blasius
Dendermonde, East-Flanders, Belgium, 9200
Sponsors and Collaborators
Flanders Medical Research Program
ev3
  More Information

No publications provided

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT01412463     History of Changes
Other Study ID Numbers: FMRP-101208
Study First Received: August 8, 2011
Last Updated: September 30, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014