Innovative siroLimus seLf Expanding drUg-eluting Stent for the treatMent of perIpheral Disease: Evaluation of Safety aNd efficAcy. The ILLUMINA Study. (ILLUMINA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- CID - Carbostent & Implantable Devices
- Enrollment
- 100
- Locations
- 10
- Primary Endpoint
- Primary patency (absence of clinically-driven target lesion revascularization or binary restenosis)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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;
Exclusion Criteria
- •Patient is pregnant or breast-feeding;
- •Patient is simultaneously participating in another investigational drug or device study;
- •Patient has any planned surgical or interventional procedure within 30 days after the study procedure;
- •Clinical conditions, disorders or allergies that limit the use of anti-platelet and/or anticoagulant therapy;
- •Severe allergy to the contrast medium or drugs used during the procedure;
- •Patients with known hypersensitivity or allergies to Sirolimus, fatty acids (such as stearic acid, palmitic acid, behenic acid) or the metal components of the stent (such as Nickel, Titanium and Tantalum);
- •Serum creatinine \> 2.5 mg/dl;
- •Myocardial infarction within the 90 days prior to enrollment;
- •Hypercoagulable state;
- •Uncontrollable hypertension;
Outcomes
Primary Outcomes
Primary patency (absence of clinically-driven target lesion revascularization or binary restenosis)
Time Frame: 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)
Event-free survival rate from Major Adverse Events
Time Frame: 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.