BIOLUX P-I First in Man Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01221610
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : February 9, 2015
Information provided by (Responsible Party):
Biotronik AG

October 14, 2010
October 15, 2010
February 9, 2015
October 2010
February 2012   (Final data collection date for primary outcome measure)
Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA). [ Time Frame: 6 months ]
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Complete list of historical versions of study NCT01221610 on Archive Site
  • 6 months binary restenosis rate [ Time Frame: 6 months ]
  • 6 months and 12 months TLR rate [ Time Frame: 6 and 12 months ]
  • 6 months and 12 months change in mean ABI [ Time Frame: 6 and 12 months ]
  • 6 months and 12 months change in Rutherford class [ Time Frame: 6 and 12 months ]
  • Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR) [ Time Frame: 6 and 12 months ]
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BIOLUX P-I First in Man Study
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).
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.
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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Atherosclerosis
  • Arteriosclerosis
  • Vascular Disease
  • Peripheral Artery Disease
  • Device: Passeo-18 Lux DRB
    Other Name: Passeo-18 Lux Drug Releasing Balloon catheter
  • Device: Standard PTA (POBA)
    Other Name: Passeo-18 PTA catheter
  • Experimental: Drug Releasing Balloon
    Passeo-18 Lux Drug Releasing Balloon catheter
    Intervention: Device: Passeo-18 Lux DRB
  • Active Comparator: Standard PT A (POBA)
    Uncoated Passeo-18 PTA catheter
    Intervention: Device: Standard PTA (POBA)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2013
February 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
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Biotronik AG
Biotronik AG
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Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Leipzig GmbH, Leipzig, Germany
Biotronik AG
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP