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Peripheral Vascular DiseasesELLIPSENCT04276311

Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb Ischemia

A study testing Percutaneous transluminal angioplasty in people with Peripheral Vascular Diseases, run by Hospital St. Joseph, Marseille, France at 8 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Lower extremity peripheral artery disease (PAD) is a major health problem leading to significant morbidity and even mortality. Patients with superficial femoral artery stenosis make up an important proportion of patients with PAD, and since this type of involvement was reported to be most commonly associated with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Vascular Diseases
What is being tested?
Percutaneous transluminal angioplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
8 sitesFrance
Study dates
4 Mar 2020to 30 Dec 2024
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

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with moderate to severe claudication: chronic symptomatic AOMI (Rutherford 2 and 3)
  • Diagnosed with de novo obstructive lesions calcified in the superficial femoral artery or in P1: tight stenosis (> 70%), calcified, layered, length ˃ 10 cm or short calcified occlusions <5 cm from the superior femoral artery and P1.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
  • Affiliated to social safety plan of beneficiary under such a plan

Who cannot join

  • Intra stent re-stenosis
  • Recent occlusions, less than 1 month old of SFA and / or P1 (probable thrombus)
  • SFA occlusion, P1 > 5 cm, from origin of SFA.
  • SFA stenosis <10 cm
  • Non calcified stenosis
  • Participants who have participated in another research study involving an investigational product in the past 12 weeks
  • Participant issuing with a safeguard measure of justice (in accordance with the low article L1122-2 of the public health code)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Hopital Prive de Provence

    Aix-en-Provence, 13595

  • Clinique Rhône Durance

    Avignon, 84000

  • Polyclinique Notre Dame

    Draguignan, 83300

  • Hopital Europeen

    Marseille, 13000

  • Hôpital Saint Joseph

    Marseille

  • Clinique Saint Georges

    Nice, 06000

  • Clinique Les Franciscaines

    Nîmes, 30000

  • Polyclinique Les Fleurs

    Ollioules, 83090

Other trials in France

About this study

Official title: Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty (With or Without Stent Placement) in the Management of Lower Limb Ischemia (ELLIPSE): "Real Life" Observational Study

Lower extremity peripheral artery disease (PAD) is a major health problem leading to significant morbidity and even mortality. Patients with superficial femoral artery stenosis make up an important proportion of patients with PAD, and since this type of involvement was reported to be most commonly associated with intermittent claudication, this patient population has been subject to intensive research on methods to prevent disease progression and further complications.

Endovascular treatment has become the first-line treatment for low-complexity femoropopliteal (FP) lesions classified as TASC (Trans Atlantic Inter-Societal Consensus) A and B. Conversely, in case of more extensive lesions (TASC C), this treatment is still under debate because of a primary permeability that is difficult to maintain over time. Recently, studies have shown the interest of drug eluting technologies in the treatment of TASC A \& B femoral-popliteal lesions, by significantly improving patency rates compared to uncoated balloons or stents.

Read more

In this context, the endovascular treatment of FP complex lesions (TASC C) continues to develop widely.

During endovascular treatment, the quality of the artery preparation has recently been identified as a factor improving outcomes. The dilatation of the artery with an uncoated balloon or POBA (Plain Old Balloon Angioplasty) is the reference method performed before stent placement or drug-coated balloons. However, some new alternatives to prepare the artery have emerged, using no more dilatation but atherectomy (Jetstream™ system).

Atherectomy appears to reduce the risk of dissections and bailout stenting and improve the acute procedural results. Its long term outcome, when associated with drug coated balloons (DCB), has recently been demonstrated in the USA to be superior to angioplasty in a single center study JET-SCE.

The purpose of this study is to evaluate the efficacy and the feasibility of atherectomy, using the Jetstream™ artery preparation associated to DCB treatment (Ranger™ Paclitaxel-Coated balloon), in symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo FP arterial lesions (TASC C).

Being tested
Percutaneous transluminal angioplasty
Medical subject headings
Peripheral Vascular Diseases

What participants receive

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

  • Percutaneous transluminal angioplastyDevice

    The purpose of this study is to evaluate the efficacy and the feasibility of atherectomy, using the Jetstream™ artery preparation associated to DCB treatment (Ranger™ Paclitaxel-Coated balloon), in symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo femoropopliteal arterial lesions (TASC C).

Study groups in NCT04276311
Study groupRoleWhat they receive
symptomatic patients with complex de novo FP arterial lesionsExperimentalin symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo FP arterial lesions (TASC C).
Receives: Device: Percutaneous transluminal angioplasty

What is being measured

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

  1. Freedom of Target lesion revascularization

    Percent of patients with freedom of any percutaneous intervention or surgical bypass on target lesions, performed because of restenosis or any other complication involving the target lesion

    Measured: 12 months

Secondary outcomes (6)

  1. Primary patency

    exempt from restenosis of the target lesion during follow-up (Doppler ultrasound)

    Measured: Baseline, Month 2, Month 6, Month12, Month 24

  2. Primary assisted patency

    patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis (Doppler ultrasound)

    Measured: Baseline, Month 2, Month 6, Month12, Month 24

  3. Secondary patency

    patency of the target lesion after treatment of a (re)occlusion of the index lesion

    Measured: Baseline, Month 2, Month 6, Month12, Month 24

  4. Late Lumen Loss

    defined as the difference between the minimal luminal diameter at the end of the procedure and the minimal luminal diameter at follow-up measured by CT Angiography.

    Measured: Baseline, Month 2-Month 6

  5. technical success of the procedure

    ability to pass through (intra-luminal passage) and dilate the lesion to obtain residual stenosis under angiography ≤30%.

    Measured: Day 0

  6. Procedural success

    technical success without undesirable major event observed within 24 hours post-procedure.

    Measured: Day 1

Timeline

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

  1. First posted19 Feb 2020
  2. Study start4 Mar 2020
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2024 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04276311
Sponsor's protocol ID
HSJ/02/2019
Acronym
ELLIPSE
Status last verified
May 2022
First submitted
3 Feb 2020
Last updated
12 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous transluminal angioplasty in people with Peripheral Vascular Diseases, run by Hospital St. Joseph, Marseille, France at 8 sites in France.

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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. 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?

Results are not available in the source record.

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?

Freedom of Target lesion revascularization (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 NCT04276311.

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 May 2022.

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