AzTrials
AzTrials

Peripheral Arterial DiseasePhase 4BeSmoothNCT02690051

BeSmooth Study, Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions

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

Completed

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

Official record
Search all trials

Trial summary

A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the treatment of Iliac Lesions. The objective of this clinical investigation is to evaluate the long-term safety and efficacy of the BeSmooth Peripheral Stent System in clinical settings post CE-certification when used according to… 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?
BeSmooth peripheral stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
4 sitesBelgium
Study dates
Oct 2014to Dec 2016
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

Who may be able to join

  • Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
  • Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
  • Patient presenting a score from 2 to 5 following Rutherford classification
  • Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
  • Patient is >18 years old
  • Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Show all 20Show fewer
  • Patient is eligible for treatment with the BeGraft Peripheral Stent Graft System (Bentley InnoMed)
  • The target lesion is either a modified TASC-II class A, B, C or D lesion with one of the listed specifications:
  • Type A lesions
  • Unilateral or bilateral stenoses of the Common Iliac Artery
  • Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
  • Type B lesions
  • Unilateral Common Iliac Artery occlusion
  • Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
  • Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
  • Type C lesions
  • Bilateral Common Iliac Artery occlusions
  • Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery
  • The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
  • There is angiographic evidence of a patent Common an Deep Femoral Artery

Who cannot join

  • PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
  • Presence of an aneurysm immediately adjacent to the site of stent implantation
  • Stenosis distal to the site of stent implantation
  • Lesions in or adjacent to essential collaterals(s)
  • Lesions in locations subject to external compression
  • Heavily calcified lesions resistant to PTA
Show all 40Show fewer
  • Patients with diffuse distal disease resulting in poor stent outflow
  • Patients with a history of coagulation disorders
  • Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy
  • Fresh thrombus formation
  • Patients with known hypersensitivity to the stent material(L605)
  • The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement:
  • Type B lesions
  • -Short (≤3 cm) stenosis of infrarenal aorta
  • Type C lesions
  • Unilateral External Iliac Artery stenosis extending into the Common Femoral Artery
  • Unilateral External Iliac Artery occlusion that involves the origins of the Internal Iliac and/or Common Femoral Artery
  • Heavily calcified unilateral External Iliac Artery occlusion with or without involvement of origins of the Internal Iliac and/or Common Femoral Artery
  • Type D lesions
  • Infra-renal aortoiliac occlusion
  • Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring treatment and not amenable to endograft placement or other lesions requiring open aortic or iliac surgery
  • Diffuse multiple stenoses involving the unilateral Common Iliac, External Iliac and Common Femoral Artery
  • Unilateral occlusions of both Common Iliac and External Iliac Artery
  • Diffuse disease involving the aorta and both iliac arteries requiring treatment
  • Bilateral occlusions of the External Iliac Artery
  • Previously implanted stent(s) at the same lesion site
  • Reference segment diameter is not suitable for the available stent design
  • Untreatable lesion located at the distal outflow arteries
  • Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
  • Patients refusing treatment
  • Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
  • Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
  • Perforation at the angioplasty site evidenced by extravasation of contrast medium
  • Patients with a history of prior life-threatening contrast medium reaction
  • Patients with uncorrected bleeding disorders
  • Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
  • Life expectancy of less than twelve months
  • Any planned surgical intervention/procedure within 30 days of the study 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

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • OLV Hospital

    Aalst, 9300

  • Imelda Hospital Bonheiden

    Bonheiden, 2820

  • AZ Sint-Blasius

    Dendermonde, 9200

  • Heilig Hart Hospital

    Tienen, 3300

Other trials in Belgium

About this study

Official title: BeSmooth Study, a Physician-initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions

A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the treatment of Iliac Lesions.

The objective of this clinical investigation is to evaluate the long-term safety and efficacy of the BeSmooth Peripheral Stent System in clinical settings post CE-certification when used according to the indications of the IFU.

Being tested
BeSmooth peripheral stent
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.

  • BeSmooth peripheral stentDevice

    patients treated with the BeSmooth Peripheral Stent System

Study groups in NCT02690051
Study groupRoleWhat they receive
BeSmooth Peripheral Stent systemExperimentalPatients treated with the BeSmooth Peripheral Stent System
Receives: Device: BeSmooth peripheral stent

What is being measured

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

  1. Primary Patency at 12 months

    defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.

    Measured: 12 months

Secondary outcomes (10)

  1. Primary Patency at 1 & 6 month

    Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up.

    Measured: 1 and 6 months

  2. Stent Occlusion Rate at 1,6 and 12-month follow-up

    100% (re)occlusion rate within the study stent

    Measured: up to 12 months

  3. ABI at 1,6 and 12-month follow-up, compared with baseline

    Ankle-Brachial index measurements at 1,6 and 12-month FU visit, compared with measurements at baseline (pre operatively)

    Measured: up to 12 months

  4. Amputation rate at 1,6 and 12-month follow-up

    Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee.

    Measured: up to 12 months

  5. Performance success rate at baseline, defined as restoration of blood flow

    Device success, restoration of blood flow during index procedure

    Measured: during the index study procedure

  6. In-stent restenosis rate

    restenosis rate within the study stent

    Measured: up to 12 months

  7. Freedom from Target Lesion Revascularization

    Freedom from Target Lesion Revascularization (TLR), defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.

    Measured: up to 12 months

  8. Serious Adverse Events

    Serious Adverse Events (SAEs), defined according to ISO 14155:2011 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: up to 12 months

  9. Technical success

    The ability to achieve final residual angiographic stenosis no greater than 30%

    Measured: during the index study procedure

  10. Clinical success at follow-up is defined as an improvement of Rutherford Classification at 1-,6- and 12-month follow-up

    Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification

    Measured: up to 12 months

Timeline

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

  1. First posted24 Feb 2016 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02690051
Sponsor's protocol ID
FMRP-140702
Acronym
BeSmooth
Status last verified
Feb 2016
First submitted
2 Feb 2016
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BeSmooth peripheral stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 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?

The sponsor lists 20 inclusion and 40 exclusion criteria. 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Primary Patency at 12 months (time frame: 12 months). 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 NCT02690051.

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 12 Jan 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in