Status:
COMPLETED
Physician-Initiated Trial Investigating the Efficacy of Endovascular Treatment of Femoropopliteal Arterial Stenotic Disease With the Biotronik Passeo-18 Lux Drug Releasing Balloon and the Biotronik Pulsar-18 Stent (Comparing With 4EVER Trial Results)
Lead Sponsor:
Flanders Medical Research Program
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this clinical investigation is to evaluate the short- and long-term (up to 24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing balloon and by Pu...
Detailed Description
Ever since its introduction, one of the major limitations of endovascular therapy is the occurrence of restenosis after treatment. Factors contributing to loss of primary patency after percutaneous tr...
Eligibility Criteria
Inclusion
- General
- De novo lesions 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 time
- Patients 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
- Angiographic
- The target lesions are located within the native SFA: 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 \>50% or occlusion
- Length of the target lesion is ≤ 19 cm by visual estimation and can be covered with one stent
- Target vessel diameter visually estimated is ≥4 mm and ≤6 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 :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02211664
Start Date
June 1 2014
End Date
March 1 2018
Last Update
August 13 2018
Active Locations (5)
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1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
2
OLV Hospital
Aalst, Belgium, 9300
3
Imelda Hospital
Bonheiden, Belgium, 2820
4
AZ Sint-Blasius
Dendermonde, Belgium, 9200