Peripheral Arterial Disease
Conditions
Brief summary
The aim of the prospective, multicentre, single-arm study is to assess safety and efficacy of a drug eluting stent in Nitinol alloy (NiTiDES) in term of vessel patency and composite event-free survival rate up to two years follow-up in focal/medium length lesions in patients with ischemic obstruction of superficial femoral arteries or/and proximal popliteal arteries.
Interventions
DEVICENiTiDES
Sponsors
CID - Carbostent & Implantable Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical * Patient must be over 18 years inclusive at the time of consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol; * A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at screening; * Patient has signed and dated the informed consent; * Patient has symptoms of peripheral arterial disease classified as Rutherford Category (2-4); patients with Rutherford Category 2 can be included only if a conservative and/or medication therapy was unsuccessful. * Patient has a resting ABI \<0.9 or at exercise if resting ABI is normal; patient with incompressible arteries (ABI \>1.2) at rest or at exercise must have a toe-brachial index (TBI) \<0.8. Angiographic * Patient has one documented stenotic or occluded atherosclerotic lesion (lesion length ≤ 14 cm) of the above-the-knee femoropopliteal artery, in one limb, that meet all of the inclusion criteria and none of the
Exclusion criteria
; * Patient has a de novo or restenotic lesion with \>50% stenosis documented angiographically and no prior stent in the target lesion; * The target lesion must be appropriately covered (margin of 5.0 mm on both sides of the stent) by one or two study stents (NiTiDES). Any occurred dissection of the target vessel must be treated with an additional stent (NiTiDES); * Tandem lesions are allowed if the distance between 2 lesions is ≤ 3 cm and the total length of all lesions ≤ 14 cm; * Guidewire successfully passed the lesion through the lumen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival rate from Major Adverse Events | 12 months after procedure | Freedom from Clinical Events Committee (CEC) adjudicated Major Adverse Event (death, target limb amputation, target limb ischemia requiring surgical intervention or surgical repair of target vessel or clinically-driven target lesion revascularization) or worsening of the Rutherford score by 2 classes, or to class 5 or 6. |
| Primary patency (absence of clinically-driven target lesion revascularization or binary restenosis) | 12 months after procedure | Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis; binary restenosis is defined as a peak systolic velocity ratio (PSVR) \>2.4 (duplex evaluation) |
Countries
France, Germany, Italy
Outcome results
None listed