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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: October 2010
Study Completion Date: August 2012
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221610

Locations
Austria
AKH Wien, Kardiovaskuläre und Interventionelle Radiologie
Vienna, Austria
Germany
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
Investigators
Principal Investigator: Dierk Scheinert, MD Park-Krankenhaus Leipzig GmbH, Leipzig, Germany
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01221610     History of Changes
Other Study ID Numbers: C1003
Study First Received: October 14, 2010
Last Updated: May 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

Keywords provided by Biotronik AG:
Stenosis
Occlusions
SFA
PTA
POBA
DRB

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014