Atherosclerosis Obliterans
Conditions
Keywords
femoropopliteal artery, interwoven nitinol stent, self-expanding-endovascular, TASC C and TASC D, Peripheral Arterial Disease
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.
Interventions
DEVICEEndovascular 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
Sponsors
Abbott
Nantes University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 improvement of at least one category of Rutherford classification | 24 months | clinical 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) |
| 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 |
| number of patient with sustained permeability without restenosis > 30% after reintervention | 24 months | hemodynamic effectiveness of the SuperA stent measurement |
Countries
France
Outcome results
None listed