STELLASUPERA: Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03020290

Collaborator

Abbott (Industry)

335

Enrollment

Locations

16.3

Duration (Months)

167.5

Patients Per Site

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Obliterans	Device: Endovascular treatment for PAD during medical care (SuperA stent (Abbott))

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.

Study Design

Study Type:

Observational

Actual Enrollment :

335 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Apr 10, 2018

Actual Study Completion Date :

Apr 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
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)) 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 Other Names: long femoropopliteal revascularization

Arm

Intervention/Treatment

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))

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

Other Names:

long femoropopliteal revascularization

Outcome Measures

Primary Outcome Measures

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

Number of patient with improvement of at least one category of Rutherford classification [24 months]
clinical effectiveness of the SuperA stent measurement
number of patient presenting a major adverse cardiovascular event [24 months]
clinical effectiveness of the SuperA stent measurement
number of patient presenting a major adverse limb event [24 months]
clinical effectiveness of the SuperA stent measurement
limb salvage rate measurement [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
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).
restenosis measurement [24 months]
hemodynamic effectiveness of the SuperA stent measurement
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
quality of life in patients treated with the SuperA stent [1 month]
EuroQol five dimensions questionnaire (EQ5D-3L)
quality of life in patients treated with the SuperA stent [12 months]
EQ5D-3L questionnaire
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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