Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

NCT03020290 | Completed

• 1 other identifier: RC15_0464
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 2

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.

Conditions

Atherosclerosis Obliterans

Keywords

femoropopliteal artery; interwoven nitinol stent; self-expanding-endovascular; TASC C and TASC D; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Number of patient with improvement of at least one category of Rutherford classification

  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

  12 months

Secondary Outcomes (22)

• Number of patient with improvement of at least one category of Rutherford classification

  24 months

• number of patient presenting a major adverse cardiovascular event

  24 months

• number of patient presenting a major adverse limb event

  24 months

• limb salvage rate measurement

  24 months

• rate of Target Lesion Revascularization (TLR)

  24 months

Study Arms (1)

patients with femoropopliteal lesion

patients with femoropopliteal lesion - Endovascular treatment for PAD during medical care

Device: Endovascular treatment for PAD during medical care (SuperA stent (Abbott))

Interventions

Endovascular treatment for PAD during medical care (SuperA stent (Abbott)) DEVICE

Long femoropopliteal stenting with SuperA devices during medical care. The endovascular treatment for PAD will be done during the usual medical treatment of patient. The intervention is not carried out within the framework of the research protocol

Also known as: long femoropopliteal revascularization

patients with femoropopliteal lesion

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Abbott: collaborator

Study Sites (2)

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Nantes CHU

Nantes, 44093, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Yann Goueffic, PU-PH

  yann.goueffic@chu-nantes.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 13, 2017
• Study Start: December 1, 2016
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: September 9, 2021

Record last verified: 2019-09

Locations

FR (2)