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BIOLUX P-I First in Man Study

This study has been completed.
Information provided by (Responsible Party):
Biotronik AG Identifier:
First received: October 14, 2010
Last updated: February 6, 2015
Last verified: February 2015
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.

Condition Intervention
Atherosclerosis Arteriosclerosis Vascular Disease Peripheral Artery Disease Device: Passeo-18 Lux DRB Device: Standard PTA (POBA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA). [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Releasing Balloon
Passeo-18 Lux Drug Releasing Balloon catheter
Device: Passeo-18 Lux DRB
Other Name: Passeo-18 Lux Drug Releasing Balloon catheter
Active Comparator: Standard PT A (POBA)
Uncoated Passeo-18 PTA catheter
Device: Standard PTA (POBA)
Other Name: Passeo-18 PTA catheter


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01221610

AKH Wien, Kardiovaskuläre und Interventionelle Radiologie
Vienna, Austria
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin, Germany
Parkkrankenhaus Leipzig Südost GmbH
Leipzig, Germany
Institut für diagnostische und interventionelle Radiologie, Klinikum Rosenheim
Rosenheim, Germany
Sponsors and Collaborators
Biotronik AG
Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Leipzig GmbH, Leipzig, Germany
  More Information

Responsible Party: Biotronik AG Identifier: NCT01221610     History of Changes
Other Study ID Numbers: C1003
Study First Received: October 14, 2010
Last Updated: February 6, 2015

Keywords provided by Biotronik AG:

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases processed this record on September 21, 2017