AzTrials
AzTrials

AtherosclerosisNCT02710656

Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease

A study testing Legflow® balloon and Standard PTA in people with Atherosclerosis, run by Cardionovum GmbH at 9 sites in 3 countries.

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 randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis
What is being tested?
Legflow® balloon and Standard PTA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
9 sitesin 3 countries
Study dates
Mar 2016to Nov 2019
Phase
Interventional
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

  • Patient must sign the informed consent form prior to the index-procedure.
  • Patient must be older than 18 years.
  • Patient with Rutherford 2, 3 and 4..
  • Target lesion is an occlusion or ≥70% stenosis (visual estimate) located in SFA or popliteal artery (P1 -P2).
  • Maximum length of the target lesion is 13 cm.
  • Target lesion is TASC A, B or C.
Show all 10Show fewer
  • Target lesion is a de novo lesion or restenotic lesion (previously POBA treated, in-stent restenosis is not allowed).
  • Inflow arteries are free from hemodynamically significant obstruction (i.e. ≥ 50% diameter stenosis). It is allowed to treat inflow lesions during the index-procedure if the result is ≤ 30% diameter stenosis (treatment with DCB or DES is not allowed). Treatment of a non-target lesion in the target vessel is allowed if the nontarget lesion is considered to be an inflow lesion.
  • Popliteal artery P3 segment (below knee popliteal artery) is free from hemodynamically significant obstruction (i.e. ≥ 50%). Treatment of a lesion in this segment is not allowed during the index-procedure.
  • At least 1 patent (< 50% diameter stenosis) below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle as confirmed by baseline angiography.

Who cannot join

  • Patient is already included in this study (recruitment of the contralateral leg is not allowed).
  • Patient has a known intolerance to antiplatelet therapy or contrast agent.
  • Patient with known sensitivity to Paclitaxel.
  • Patient is pregnant or patient intends to become pregnant within 1 year after the index-procedure.
  • Patient takes esomeprazole or omeprazole.
  • Patient with serum creatinine >2.0 mg/dL or renal dialysis.
Show all 19Show fewer
  • Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
  • Patient has a life expectancy <2 years.
  • Patient with Rutherford 0, 1 , 5 and 6.
  • Patient has a target lesion that is severely calcified (grade 3 and grade 4).
  • Patient with a TASC D lesion.
  • Patient has an acute thrombus or aneurysm in the target vessel.
  • Patient has a target lesion that cannot be crossed with a guidewire.
  • Target vessel has been treated previously with a DCB or a DES.
  • Treatment of outflow lesions during the index-procedure.
  • Patients with significant disease of all 3 infrapopliteal vessels (i.e. ≥ 50% diameter stenosis in each vessel).
  • Any scheduled surgery within 3 months after the index-procedure that would necessitate the discontinuation of clopidogrel.
  • Patients with previous bypass surgery involving the SFA.
  • Patient has cirrhosis of the liver.

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

Belgium5 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • AZ Sint-Jan

    Bruges, 8000

  • ZOL (Ziekenhuis Oost-Limburg)

    Genk, 3600

  • Jessa hospital

    Hasselt, 3500

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

France3 sites

  • CHU Bordeaux

    Bordeau, 33076

  • CHU Cermont-Ferrand

    Clermont-Ferrand

  • CH Mont-de-Marsan

    Mont-de-Marsan

Other trials in France

Germany1 site

  • Klinikum Arnsberg

    Arnsberg

Other trials in Germany

About this study

Official title: Multicenter Randomized Controlled Trial Comparing Legflow - DCB (Cardionovum) Versus Bare Balloon Angioplasty for the Treatment of Atherosclerotic Disease in the Superficial Femoral & Popliteal Segment

A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.

Read the detailed description

This interventional study will collect data about the treatment of de novo lesions or restenotic lesions. Restenotic lesions that are previously DCB (drug coated balloon) treated or in-stent restenosis are excluded in this study.

The primary objective of this randomized study is to compare the efficacy of the DCB (Legflow - Cardionovum) versus POBA for the treatment of de novo lesions or restenosis in the SFA and in the popliteal artery (segment P1 -P2) by assessing the binary restenosis rate with duplex ultrasonography at 12 months.

The secondary endpoints are the assessment of the immediate procedural outcome, distribution of Rutherford, mortality, target lesion revascularization (TLR), target extremity revascularization (TER), amputation and anklebrachial index (ABI).

For each patient enrolled, data will be collected up to 12 months after the procedure.

Conditions
Atherosclerosis
Being tested
Legflow® balloon, Standard PTA
Keywords
Atherosclerosis, SFA, Poplitea, Drug coated balloon, Angioplasty, Restenosis, Peripheral artery disease (PAD)
Medical subject headings
Atherosclerosis, Peripheral Arterial Disease

What participants receive

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

  • Legflow® balloonDevice

    Also called Paclitaxel eluting balloon

    Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel

  • Standard PTADevice

    Also called POBA

    Percutaneous angioplasty performed with a standard balloon

Study groups in NCT02710656
Study groupRoleWhat they receive
Drug Coated Balloon (DCB) - Legflow®ExperimentalPercutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting Legflow® balloon.
Receives: Device: Legflow® balloon
Standard PTA - POBAActive comparatorPercutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug eluting balloon (POBA, plain old balloon angioplasty).
Receives: Device: Standard PTA

What is being measured

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

  1. Efficacy measured by binary restenosis rate

    Binary restenosis rate determined by duplex ultrasonography at 1, 6 and 12 months afte procedure. Binary restenosis is defined as a re-obstruction ≥50% of the target lesion (peak systolic velocity ratio > 2.4).

    Measured: Until 12 months after procedure

Secondary outcomes (7)

  1. Immediate procedural outcome of percutaneous balloon angioplasty

    Investigator opinion of procedural and technical success of the percutaneous angioplasty. Opinion of investigator (yes/no) is recorded in the CRF for technical success and procedural success.

    Measured: From start of procedure surgery until completion of procedure surgery (Percutaneous balloon angioplasty)

  2. Rutherford

    Distribution of Rutherford stages during follow-up as compared to baseline.

    Measured: Baseline until 12 months after procedure

  3. Mortality

    30-day mortality, 6-months mortality and overall mortality at 12 months.

    Measured: Until 12 months after procedure

  4. Repeated target lesion revascularization (TLR) rate

    TLR is defined as a repeated procedure (endovascular or surgical) due to a problem arising from the lesion (+1 cm proximally and distally to include edge phenomena) initially treated in surviving patients with preserved limb.

    Measured: Until 12 months after procedure

  5. Repeated target extremity revascularization (TER) rate

    TER is defined as a procedure (endovascular or surgical) due to a problem arising in the ipsilateral traject (iliac, femoropopliteal and below the knee arteries) remote from the lesion initially treated in surviving patients with preserved limb.

    Measured: Until 12 months after procedure

  6. Minor and major amputation rate

    Occurrence of minor (below the ankle) and major (above the ankle) amputations.

    Measured: Until 12 months after procedure

  7. Ankle-Brachial Index (ABI)

    Reporting of Ankle-Brachial Index compared to baseline

    Measured: Baseline until 12 months after procedure

Timeline

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

  1. First posted17 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionOct 2019
  4. Study completionNov 2019

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02710656
Sponsor's protocol ID
MAGNIFICENT
Status last verified
Jan 2020
First submitted
7 Mar 2016
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Legflow® balloon and Standard PTA in people with Atherosclerosis, run by Cardionovum GmbH at 9 sites in 3 countries.

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 10 inclusion and 19 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 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Belgium, France, Germany. 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.

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?

Efficacy measured by binary restenosis rate (time frame: Until 12 months after procedure). 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 NCT02710656.

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 23 Jan 2020.

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