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

NCT04276311 | Unknown

• 1 other identifier: HSJ/02/2019
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

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).

Conditions

Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (6)

• Primary patency

  Baseline, Month 2, Month 6, Month12, Month 24

• Primary assisted patency

  Baseline, Month 2, Month 6, Month12, Month 24

• Secondary patency

  Baseline, Month 2, Month 6, Month12, Month 24

• Late Lumen Loss

  Baseline, Month 2-Month 6

• technical success of the procedure

  Day 0

Study Arms (1)

symptomatic patients with complex de novo FP arterial lesions

EXPERIMENTAL

in symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo FP arterial lesions (TASC C).

Device: Percutaneous transluminal angioplasty

Interventions

Percutaneous transluminal angioplasty DEVICE

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).

symptomatic patients with complex de novo FP arterial lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (8)

Hopital Prive de Provence

Aix-en-Provence, 13595, France

Location

Clinique Rhône Durance

Avignon, 84000, France

Location

Polyclinique Notre Dame

Draguignan, 83300, France

Location

Hopital Europeen

Marseille, 13000, France

Location

Hôpital Saint Joseph

Marseille, France

Location

Clinique Saint Georges

Nice, 06000, France

Location

Clinique Les Franciscaines

Nîmes, 30000, France

Location

Polyclinique Les Fleurs

Ollioules, 83090, France

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 19, 2020
• Study Start: March 4, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2024
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)