Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

Completed

• Conditions: Atherosclerosis Obliterans
• Interventions: Device: Endovascular treatment for PAD during medical care (SuperA stent (Abbott))

• Registration Number: NCT03020290
• Lead Sponsor: Nantes University Hospital

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Primary Completion: 2018-04-10
• Study Completion: 2018-04-10
• Status Verified: 2019-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

Not provided

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with femoropopliteal lesion	Endovascular treatment for PAD during medical care (SuperA stent (Abbott))	patients with femoropopliteal lesion - Endovascular treatment for PAD during medical care

Primary Outcome Measures

Name	Time	Method
Number of patient with improvement of at least one category of Rutherford classification	12 months	To evaluate the sustained clinical effectiveness of the SuperA stent (Abbott) at 12-month for TASC C and D atherosclerotic femoropopliteal lesions in patients with symptomatic primary artery disease (PAD) (RUTHERFORD 2 to 6).; Improvement of at least 1 category of Rutherford classification for claudicants.; Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia

Secondary Outcome Measures

Name	Time	Method
restenosis measurement	24 months	hemodynamic effectiveness of the SuperA stent measurement
number of patient presenting a major adverse cardiovascular event	24 months	clinical effectiveness of the SuperA stent measurement
variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery	24 months	hemodynamic effectiveness of the SuperA stent measurement; (restenosis, thrombosis) and morphologic criteria (stenting length, stent fracture).
number of patient presenting a major adverse limb event	24 months	clinical effectiveness of the SuperA stent measurement
Number of patient with improvement of at least one category of Rutherford classification	24 months	clinical effectiveness of the SuperA stent measurement
rate of Target Lesion Revascularization (TLR)	24 months	Effectiveness of the SuperA stent measurement
rate of Target Extremity Revascularization (TER)	24 months	Effectiveness of the SuperA stent measurement
number of patient with sustained permeability without restenosis > 30% in lack of reintervention	24 months	hemodynamic effectiveness of the SuperA stent measurement
number of patient with sustained permeability without restenosis > 30% after reintervention	24 months	hemodynamic effectiveness of the SuperA stent measurement
limb salvage rate measurement	24 months	clinical effectiveness of the SuperA stent measurement
quality of life in patients treated with the SuperA stent	24months	EQ5D-3L questionnaire
Assessment of vessel calcification rate	24months	For predictive factors of failure
thrombosis measurement	24 months	hemodynamic effectiveness of the SuperA stent measurement
stenting length measurement	24 months	morphologic criteria of effectiveness of the SuperA stent measurement
stent fracture measurement	24 months	morphologic criteria of effectiveness of the SuperA stent measurement
Assessment of elongation rate of SuperA	24months	For predictive factors of failure
Assessment of stent diameter	24months	For predictive factors of failure
Number of patient presenting cardiovascular comorbidity	24months	For predictive factors of failure
Number of patient presenting a renal dysfunction (creatinine clearance < 60 mL/min and/or dialysis)	24months	For predictive factors of failure
Number of patient treated with anti-platelet therapy	24months	For predictive factors of failure

Trial Locations

Locations (2)

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

Nantes CHU; 🇫🇷 Nantes, France