Clinical trial NCT03020290: Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents
Official title: Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis Obliterans
Keywords: femoropopliteal artery
interwoven nitinol stent
self-expanding-endovascular
TASC C and TASC D
Peripheral Arterial Disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2017-01-13
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included in this study are major patients and have lower limb arteriopathy requiring a therapeutic gesture in the femoro-popliteal segment. The inclusion in this study will be proposed to the patients during the consultation of preoperative vascular surgery or during the hospitalization, until the day after their intervention. The number of subjects planned is 50.

In the case where the patient has bilateral femoropopliteal lesions, the limbs being treated in separate hospitalizations, both members may be treated with SuperA stents. The two members will then be considered independently of each other.

Patients with associated lesions requiring treatment, any artery confused, may be treated at the same operative time if deemed necessary by the surgeon.

Brief summary: Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).

The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criteria, the possible influence of calcifications and the quality of life of patients.

The SuperA stent treatment is not specifically provided for by the Protocol but is carried out within the framework of the care. This study is an observationnal study.

Detailed description: Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.

Patient can be included up to the next day of the intervention.

Endovascular treatment of femoropopliteal lesion with SuperA stents during medical care:

Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.

The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.

A control arteriography will be done before the implantation of the stent and at the end of the intervention to assess the success of the procedure.

If needed, endovascular treatment could be realized on the inflow or outflow in the same time.

Patient follow-up :

Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).

The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.

All clinical surveillance events, complications and re-hospitalizations will be collected.

Eligibility criteria: Inclusion criteria:

* Age \> 18 years,
* Symptomatic PAD, Rutherford 2 to 6
* Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
* De novo femoropopliteal lesion
* Patient informed of the study and oral authorization collected

Exclusion Criteria:

* Under-age patient
* Patient of age, but under legal guardianship or care
* Potentially pregnant women
* Patients do not understand the French language
* Asymptomatic lesion
* Acute ischemia or acute thrombosis
* Lesion already treated
* No-atherosclerotic disease
* hemostasis disorder
* severe comorbidity with life expectancy less than 2 years
* contraindication of antiplatelet (dual antiplatelet therapy required during at least 2 month post-intervention)
* patient participating in a clinical trial likely to interfer
* Comorbidity or other, according investigator, that may interferer with the conduct of the study
* lesion near to an aneurysm
* Patient follow-up impossible
* Patient refuse to participate

Primary outcomes:
measure: Number of patient with improvement of at least one category of Rutherford classification
timeFrame: 12 months
Secondary outcomes:
measure: Number of patient with improvement of at least one category of Rutherford classification
timeFrame: 24 months
measure: number of patient presenting a major adverse cardiovascular event
timeFrame: 24 months
measure: number of patient presenting a major adverse limb event
timeFrame: 24 months
measure: limb salvage rate measurement
timeFrame: 24 months
measure: rate of Target Lesion Revascularization (TLR)
timeFrame: 24 months
measure: rate of Target Extremity Revascularization (TER)
timeFrame: 24 months
measure: number of patient with sustained permeability without restenosis > 30% in lack of reintervention
timeFrame: 24 months
measure: number of patient with sustained permeability without restenosis > 30% after reintervention
timeFrame: 24 months
measure: variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery
timeFrame: 24 months
measure: restenosis measurement
timeFrame: 24 months
measure: thrombosis measurement
timeFrame: 24 months
measure: stenting length measurement
timeFrame: 24 months
measure: stent fracture measurement
timeFrame: 24 months
measure: quality of life in patients treated with the SuperA stent
timeFrame: 1 month
measure: quality of life in patients treated with the SuperA stent
timeFrame: 12 months
measure: quality of life in patients treated with the SuperA stent
timeFrame: 24months
measure: Assessment of vessel calcification rate
timeFrame: 24months
measure: Assessment of elongation rate of SuperA
timeFrame: 24months
measure: Assessment of stent diameter
timeFrame: 24months
measure: Number of patient presenting cardiovascular comorbidity
timeFrame: 24months
measure: Number of patient presenting a renal dysfunction (creatinine clearance < 60 mL/min and/or dialysis)
timeFrame: 24months
measure: Number of patient treated with anti-platelet therapy
timeFrame: 24months
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Nantes
country: France
facility: Nantes CHU
Study officials:
affiliation: yann.goueffic@chu-nantes.fr
name: Yann Goueffic, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: