Status:
COMPLETED
BIOLUX P-I First in Man Study
Lead Sponsor:
Biotronik AG
Conditions:
Atherosclerosis
Arteriosclerosis
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloo...
Eligibility Criteria
Inclusion
- Age ≥ 50 years,
- Informed consent signed by patient prior to randomization
- Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
- Rutherford Class 2 - 5 in the target limb
- Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
- Inflow free from flow-limiting lesion (\< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion has been treated successfully before the index procedure
- At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
- Successful wire crossing of the lesion
- Willingness to comply with all specified follow-up evaluations
- Male or negative pregnancy test of women in childbearing age
Exclusion
- Co-morbid conditions limiting life expectancy ≤ 1 year
- Patient currently participating in another clinical trial
- Lesions which are untreatable with PTA or other interventional techniques
- The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion
- Thrombus in the target vessel, documented by angiography
- Target lesion is severely calcified, documented by angiography
- Prior bypass surgery of target vessel
- Previously implanted stent in the target lesion
- Treatment of bifurcation required
- Planned amputation of the target limb
- Flow-limiting (\> 50% DS) Inflow lesion proximal to target lesion, left untreated
- Failure to obtain \<30% residual stenosis in a pre-existing haemodynamically significant (\>50% DS) inflow lesion in the ipsilateral iliac or proximal SFA. (DEB or DES not allowed for the treatment of inflow lesion)
- Additional hemodynamically relevant proximal and distal lesions with stenosis ≥ 50 %, except iliac arteries, are excluded. Iliac artery lesion treatments have to be successful with a residual stenosis ≤ 30 %
- Haemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy
- Phenprocoumon intake
- Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment
- Known allergy to contrast media that cannot be adequately controlled with pre-medication
- Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01221610
Start Date
October 1 2010
End Date
January 1 2013
Last Update
February 9 2015
Active Locations (5)
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1
AKH Wien, Kardiovaskuläre und Interventionelle Radiologie
Vienna, Austria
2
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
3
Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin, Germany
4
Parkkrankenhaus Leipzig Südost GmbH
Leipzig, Germany