BIOLUX P-I First in Man Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01221610
First received: October 14, 2010
Last updated: May 28, 2013
Last verified: May 2013

October 14, 2010
May 28, 2013
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01221610 on ClinicalTrials.gov Archive Site
  • 6 months binary restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 6 months and 12 months TLR rate [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • 6 months and 12 months change in mean ABI [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • 6 months and 12 months change in Rutherford class [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2012
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)
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT01221610
C1003
Yes
Biotronik AG
Biotronik AG
Not Provided
Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Leipzig GmbH, Leipzig, Germany
Biotronik AG
May 2013

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