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Peripheral Arterial DiseasePhase 4DURABILITY+NCT01412463

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

A Phase 4 study testing stent placement in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
stent placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesBelgium
Study dates
May 2011to Jan 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • Imelda Hospital

    Bonheiden, Antwerp, 2820

  • A.Z. Sint-Blasius

    Dendermonde, East-Flanders, 9200

  • University Hospital Antwerp

    Edegem, Antwerp, 2650

Other trials in Belgium

About this study

Official title: DURABILITY+ : a Prospective, Multi-center, Controlled Study Measuring the Durability in Lesions of the Superficial Femoral Artery of the Protégé Everflex+ Stent

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.

Being tested
stent placement
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stent placementDevice

    Also called Protégé EverFlex+

    • 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
Study groups in NCT01412463
Study groupRoleWhat they receive
Protégé EverFlex+ExperimentalStenting with Protégé EverFlex+
Receives: Device: stent placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days post-procedure

  2. 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.

    Measured: 12 months post-procedure

Secondary outcomes (8)

  1. Technical success

    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%

    Measured: 1 day post-procedure

  2. Primary stent patency at 1 and 6 months

    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.

    Measured: 1 and 6 months post-procedure

  3. Primary assisted patency

    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.

    Measured: 1, 6 and 12 months post-procedure

  4. Secondary patency

    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.

    Measured: 1, 6 and 12 months post-procedure

  5. Target lesion revascularization

    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.

    Measured: 12 months post-procedure

  6. limb-salvage

    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)

    Measured: 12-months post-procedure

  7. Clinical success

    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

    Measured: 1, 6 and 12 months post-procedure

  8. Serious adverse events

    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.

    Measured: 12-months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01412463
Sponsor's protocol ID
FMRP-101208
Acronym
DURABILITY+
Status last verified
Sep 2013
First submitted
8 Aug 2011
Last updated
1 Oct 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing stent placement in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Event rate (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01412463.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.

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