- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03020290
Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents (STELLASUPERA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
La Roche-sur-Yon, France, 85925
- CHD Vendée
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Nantes, France, 44093
- Nantes CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with femoropopliteal lesion
patients with femoropopliteal lesion - Endovascular treatment for PAD during medical care
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient with improvement of at least one category of Rutherford classification
Time Frame: 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 |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient with improvement of at least one category of Rutherford classification
Time Frame: 24 months
|
clinical effectiveness of the SuperA stent measurement
|
24 months
|
number of patient presenting a major adverse cardiovascular event
Time Frame: 24 months
|
clinical effectiveness of the SuperA stent measurement
|
24 months
|
number of patient presenting a major adverse limb event
Time Frame: 24 months
|
clinical effectiveness of the SuperA stent measurement
|
24 months
|
limb salvage rate measurement
Time Frame: 24 months
|
clinical effectiveness of the SuperA stent measurement
|
24 months
|
rate of Target Lesion Revascularization (TLR)
Time Frame: 24 months
|
Effectiveness of the SuperA stent measurement
|
24 months
|
rate of Target Extremity Revascularization (TER)
Time Frame: 24 months
|
Effectiveness of the SuperA stent measurement
|
24 months
|
number of patient with sustained permeability without restenosis > 30% in lack of reintervention
Time Frame: 24 months
|
hemodynamic effectiveness of the SuperA stent measurement
|
24 months
|
number of patient with sustained permeability without restenosis > 30% after reintervention
Time Frame: 24 months
|
hemodynamic effectiveness of the SuperA stent measurement
|
24 months
|
variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery
Time Frame: 24 months
|
hemodynamic effectiveness of the SuperA stent measurement (restenosis, thrombosis) and morphologic criteria (stenting length, stent fracture). |
24 months
|
restenosis measurement
Time Frame: 24 months
|
hemodynamic effectiveness of the SuperA stent measurement
|
24 months
|
thrombosis measurement
Time Frame: 24 months
|
hemodynamic effectiveness of the SuperA stent measurement
|
24 months
|
stenting length measurement
Time Frame: 24 months
|
morphologic criteria of effectiveness of the SuperA stent measurement
|
24 months
|
stent fracture measurement
Time Frame: 24 months
|
morphologic criteria of effectiveness of the SuperA stent measurement
|
24 months
|
quality of life in patients treated with the SuperA stent
Time Frame: 1 month
|
EuroQol five dimensions questionnaire (EQ5D-3L)
|
1 month
|
quality of life in patients treated with the SuperA stent
Time Frame: 12 months
|
EQ5D-3L questionnaire
|
12 months
|
quality of life in patients treated with the SuperA stent
Time Frame: 24months
|
EQ5D-3L questionnaire
|
24months
|
Assessment of vessel calcification rate
Time Frame: 24months
|
For predictive factors of failure
|
24months
|
Assessment of elongation rate of SuperA
Time Frame: 24months
|
For predictive factors of failure
|
24months
|
Assessment of stent diameter
Time Frame: 24months
|
For predictive factors of failure
|
24months
|
Number of patient presenting cardiovascular comorbidity
Time Frame: 24months
|
For predictive factors of failure
|
24months
|
Number of patient presenting a renal dysfunction (creatinine clearance < 60 mL/min and/or dialysis)
Time Frame: 24months
|
For predictive factors of failure
|
24months
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Number of patient treated with anti-platelet therapy
Time Frame: 24months
|
For predictive factors of failure
|
24months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yann Goueffic, PU-PH, yann.goueffic@chu-nantes.fr
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC15_0464
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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