Claudication, Peripheral Vascular Disease
Conditions
Keywords
peripheral Vascular Disease, claudication, rest pain
Brief summary
The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device. The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).
Interventions
DEVICE4F portfolio products from Biotronik
4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18
Sponsors
Flanders Medical Research Program
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
* De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment * Patient presenting with a score from 2 to 4 according to the Rutherford classification * Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times * Patient is \>18 years old * Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study * Prior to enrollment, the target lesion was crossed with standard guidewire manipulation * Patient is eligible for treatment with 4F compatible devices Angiographic Inclusion Criteria: * The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis. * The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion * Length of the target lesion is =20 cm by visual estimation and can be covered with one stent * Target vessel diameter visually estimated is =4 mm and =6.5 mm * There is angiographic evidence of at least one-vessel-runoff to the foot
Exclusion criteria
* Presence of another stent in the target vessel that was placed during a previous procedure * Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis * Previous bypass surgery in the same limb * Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics * Patients who exhibit persistent acute intraluminal thrombus at the target lesion site * Perforation at the angioplasty site evidenced by extravasation of contrast medium * Patients with known hypersensitivity to nickel-titanium * Patients with uncorrected bleeding disorders * Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding * Life expectancy of less than 12 months * Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \> 30% * Use of thrombectomy, atherectomy or laser devices during procedure * Any planned surgical intervention/procedure 30 days after the study procedure * Any patient considered to be hemodynamically unstable at onset of procedure * Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention | 12 months | Primary patency at 12 months, defined as freedom from \>50% restenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 1 day post-procedure | Technical success, defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging. |
| Puncture site complications | 10 days | Number of puncture site complications in the absence of a closure device after intervention |
| Primary patency | 6- & 24-month follow-up | Primary patency rate at 6- & 24-month follow-up, defined as freedom from \>50% restenosis at 6 & 24 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \<2.5 in the target vessel with no reintervention. |
| Clinical success | 6-, 12- & 24-month follow-up | Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12- & 24-month follow-up of one class or more as compared to the pre-procedure |
| Stent fracture rate at 12- & 24-month follow-up | 12- & 24-month follow-up | Stent fracture rate at 12- & 24-month follow-up (in patient who were treated with stentplacement), as determined according the following classification on x-ray: 1. Class 0 : no strut factures 2. Class I : single tine fracture 3. Class II : multiple tine factures 4. Class III : Stent fracture(s) with preserved alignment of the components 5. Class IV : Stent fracture(s) with mal-alignment of the components 6. Class V : Stent fracture(s) in a trans-axial spiral configuration |
Countries
Belgium, Germany
Outcome results
None listed