Clinical trial NCT01221610: BIOLUX P-I First in Man Study
Official title: A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Arteriosclerosis
Vascular Disease
Peripheral Artery Disease
Keywords: Stenosis
Occlusions
SFA
PTA
POBA
DRB
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2010-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 50 years,
2. Informed consent signed by patient prior to randomization
3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
4. Rutherford Class 2 - 5 in the target limb
5. Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
6. 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
7. At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
8. Successful wire crossing of the lesion
9. Willingness to comply with all specified follow-up evaluations
10. Male or negative pregnancy test of women in childbearing age

Exclusion Criteria:

1. Co-morbid conditions limiting life expectancy ≤ 1 year
2. Patient currently participating in another clinical trial
3. Lesions which are untreatable with PTA or other interventional techniques
4. 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
5. Thrombus in the target vessel, documented by angiography
6. Target lesion is severely calcified, documented by angiography
7. Prior bypass surgery of target vessel
8. Previously implanted stent in the target lesion
9. Treatment of bifurcation required
10. Planned amputation of the target limb
11. Flow-limiting (\> 50% DS) Inflow lesion proximal to target lesion, left untreated
12. 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)
13. 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 %
14. 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
15. Phenprocoumon intake
16. Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment
17. Known allergy to contrast media that cannot be adequately controlled with pre-medication
18. Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)

Primary outcomes:
measure: Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).
timeFrame: 6 months
Secondary outcomes:
measure: 6 months binary restenosis rate
timeFrame: 6 months
measure: 6 months and 12 months TLR rate
timeFrame: 6 and 12 months
measure: 6 months and 12 months change in mean ABI
timeFrame: 6 and 12 months
measure: 6 months and 12 months change in Rutherford class
timeFrame: 6 and 12 months
measure: Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR)
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH Wien, Kardiovaskuläre und Interventionelle Radiologie
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen
city: Berlin
country: Germany
facility: Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge
city: Leipzig
country: Germany
facility: Parkkrankenhaus Leipzig Südost GmbH
city: Rosenheim
country: Germany
facility: Institut für diagnostische und interventionelle Radiologie, Klinikum Rosenheim
Study officials:
affiliation: Park-Krankenhaus Leipzig GmbH, Leipzig, Germany
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
References: