Status:
COMPLETED
4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease
Lead Sponsor:
Flanders Medical Research Program
Conditions:
Peripheral Vascular Disease
Claudication
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 / Astro...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01413139
Start Date
July 1 2010
End Date
September 1 2013
Last Update
October 1 2013
Active Locations (5)
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1
Imelda hospital
Bonheiden, Antwerpen, Belgium, 2820
2
Universitair ziekenhuis antwerpen
Edegem, Antwerpen, Belgium, 2650
3
AZ Sint Blasius
Dendermonde, Oost-Vlaanderen, Belgium, 9200
4
Park-Krankenhaus Leipzig
Leipzig, Germany, 04289