The BARISTA study tests the safety and efficacy of the Restorer stent from the company iVascular. This stent is a medical device that is already approved for use in Europe, to treat stenotic (narrowed) iliac arteries. 200 Belgian patients from 13 different hospitals will be included in this study. Patients will be medically monitored for 2 years from the day of the study procedure. The treatment of the stenotic iliac arteries will be according to the standard of care, using the Restorer stent. This endovascular treatment consists of introducing the necessary materials in the blood vessels by a puncture in the groin under general or local anaesthesia, after which a thin plastic tube will be inserted into the femoral artery through the puncture site, until the stenotic iliac artery is reached. Medical imaging is done by angiography. The stenotic/occluded section of the artery will first be dilated by inserting and inflating a balloon. Next, the Restorer stent will be placed and, if necessary, another balloon may be inserted and inflated to allow the stent to fit nicely to the vessel wall and optimise the result. As per standard of care, follow-up will be done in the hospital after 1, 6, 12, and 24 months. During these visits, an ultrasound scan of the treated artery will be taken to evaluate the patency of the blood vessel. Also, two short questionnaires will be completed asking about the quality of life and walking difficulties. The use of medication will be recorded. If adverse events are experienced, they will be reported.
Prospective, single-arm, multicentre, physician-initiated clinical study to assess the long-term (up to 24 months) safety and efficacy of the RESTORER peripheral stent system (iVascular) for the treatment of iliac lesions in 200 subjects, in a controlled clinical setting post CE-certification when used according to the IFU with focus on the treatment of complex TASC A, B, C and D Aorto-iliac lesions. The primary endpoint of the study is freedom of any TLR, major amputation or restenosis (defined as significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio greater than 2.4) within 12 months. Secondary endpoints are: technical success during procedure, and during the follow-up period: primary patency, stent graft occlusion rate, ABI, freedom from target lesion revascularization, clinical success (improvement of Rutherford classification), change in walking impairment questionnaire, change in quality of life questionnaire, freedom from above-the-ankle target limb amputation, and mortality. A subanalysis will be done to compare the results using the TASC classification, lesion location (AIE, AIC, bilateral, kissing configuration), gender, diabetes mellitus and Rutherford in terms of patency, frequency of TLR and clinical outcome at 12 and 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Not applicable (only one intervention)
GZA ziekenhuizen
Antwerp, Antwerp, Belgium
UZA
Antwerp, Antwerp, Belgium
Jessa
Hasselt, Limburg, Belgium
CHU Liège
Liège, Liège, Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
Vitaz
Sint-Niklaas, Oost-Vlaanderen, Belgium
AZ Sint Jan Brugge
Bruges, West-Vlaanderen, Belgium
O.L.V. Hospital
Aalst, Belgium
Imelda Hospital
Bonheiden, Belgium
A.Z. Sint-Blasius
Dendermonde, Belgium
...and 4 more locations
Freedom from TLR
Freedom from any Target Lesion Revascularization (TLR) at 12 months
Time frame: 12 months
Freedom from major amputation
Freedom from amputation above the ankle
Time frame: 12 months
Freedom from restenosis
No significant stenosis on duplex ultrasound (\>50% stenosis or systolic velocity ratio greater than 2.4)
Time frame: 12 months
Technical success
final residual angiographic stenosis \<30%
Time frame: 1 month
Primary patency rate
lack of restenosis and no need for reintervention of the target lesion
Time frame: 6, 12, and 24 months
Stent graft occlusion rate
Presence or absence of occlusion
Time frame: 1, 6, 12, and 24 months
ABI
comparison of Ankle Brachial Index at follow-up compared to baseline ABI
Time frame: 6, 12, and 24 months
Freedom from Target Lesion Revascularization
freedom from repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge
Time frame: 12 and 24 months
Clinical improvement of at least one Rutherford classification
Clinical improvement of at least one Rutherford classification (RCC) compared to pre-procedure RCC
Time frame: baseline, 6, 12, 24 months
Change in Quality of Life
Change in Quality-of-Life Questionnaire (EQ5D) at follow-up, compared to baseline
Time frame: baseline, 6, 12, and 24 months
Limb salvage
Freedom from any above-the-ankle target limb amputation
Time frame: 6, 12, 24 months
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