Clinical trial NCT04276311: Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb Ischemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Vascular Diseases
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Freedom of Target lesion revascularization
timeFrame: 12 months
Secondary outcomes:
measure: Primary patency
timeFrame: Baseline, Month 2, Month 6, Month12, Month 24
measure: Primary assisted patency
timeFrame: Baseline, Month 2, Month 6, Month12, Month 24
measure: Secondary patency
timeFrame: Baseline, Month 2, Month 6, Month12, Month 24
measure: Late Lumen Loss
timeFrame: Baseline, Month 2-Month 6
measure: technical success of the procedure
timeFrame: Day 0
measure: Procedural success
timeFrame: Day 1
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Hopital Prive de Provence
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Draguignan
country: France
facility: Polyclinique Notre Dame
city: Marseille
country: France
facility: Hopital Europeen
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Nice
country: France
facility: Clinique Saint Georges
city: Nîmes
country: France
facility: Clinique Les Franciscaines
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
Study officials:
References: