BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01867736
First received: May 27, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal 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: BIOTRONIK's - First in Men Study of the Passeo-18 LUX Drug Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Subjects Requiring Revascularization of Infrapopliteal Arteries (BIOLUX P-II).

Resource links provided by NLM:


Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • Safety: Major adverse event rate (MAE), defined as all cause death, major amputation of target extremity, target lesion thrombosis, target lesion revascularisation (TLR)and target vessel revascularization (TVR) at 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Performance: Target lesion primary patency rate at 6 months assessed by quantitative vascular angiogram (QVA). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target lesion failure, assessed by target lesion revascularization (TLR) rate at 6 months and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization (TVR) rate at 6 months and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Binary re-stenosis rate at 6 months, assessed by QVA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Major adverse event rate, defined as all cause death, major amputation of target extremity, target lesion thrombosis, TLR and TVR at 6 months and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Change in mean ABI at discharge, 30 days, 6 months and 12 months [ Time Frame: Discharge, 30 days, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Change in Rutherford classification at 30 days, 6 months and 12 months [ Time Frame: 30 days, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Quality of life evaluation, assessed by EQ5D questionnaire at baseline, 30 days, 6 months and 12 months [ Time Frame: Baseline, 30 days, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Duplex based primary patency at 30 days, 6 months and 12 months [ Time Frame: 30 days, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Procedural success, defined as successful vascular access, completion of endovascular procedure and immediate morphologic success with a residual stenosis <30%. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Device success, defined as exact deployment according to Instructions For Use [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Technical success, defined as device or procedural success without the occurrence of major adverse events during the hospital stay. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days ] [ Designated as safety issue: Yes ]
  • Late Lumen Loss [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Passeo-18 Lux DRB
Passeo-18 Lux Drug Releasing Balloon catheter
Device: Passeo-18 Lux DRB
Other Name: Passeo-18 LUX Drug Releasing PTA Balloon Catheter
Active Comparator: Standard PTA (POBA)
Uncoated Passeo-18 PTA balloon catheter
Device: Standard PTA (POBA)
Other Name: Uncoated Passeo-18 PTA balloon catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has provided written informed consent.
  2. Subject is willing and able to comply with follow-up evaluations.
  3. Subject is ≥ 18 years old.
  4. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries ≥ 30 mm. Lesions should not extend beyond the ankle joint.
  5. A maximum of 2 different vessels can be treated: successful wire crossing is required for the first target vessel before randomization occurs.
  6. Subject with PAD or critical limb ischemia according to the current guidelines in need for urgent revascularization to relieve symptoms and improve walking capacity.
  7. Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.
  8. Inflow free from flow-limiting lesion confirmed by angiography. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion(s) have been treated successfully before the index procedure, with a maximum residual stenosis of 30% per visual assessment.
  9. At least one non-occluded crural vessel with angiographically documented run-off to the foot.
  10. Successful wire crossing of the lesion.

Exclusion Criteria:

  1. Flow-limiting (> 50% DS) inflow lesion proximal to target lesion, left untreated.
  2. Failure to obtain <30% residual stenosis in a pre-existing haemodynamically significant (>50% DS) inflow lesion (DEB or DES not allowed for the treatment of inflow lesions).
  3. Infrapopliteal lesions extending beyond the ankle joint and involving crural vessels.
  4. Acute thrombus in the target vessel (eg complication of inflow lesion treatment) documented by angiogram, if not treated successfully prior to enrolment).
  5. Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure.
  6. Previous bypass surgery of target vessel.
  7. Previously implanted stent in target lesion.
  8. Haemorrhagic diathesis or coagulopathy or other disorders such as gastrointestinal ulcerations or cerebral disorders that would restrict prescription of dual anti-platelet therapy.
  9. Subject with hepatic failure, deep vein thrombosis, thrombophlebitis, systemic lupus erythematous or subject is on immunosuppressant therapy.
  10. Subject with acute MI ≤ 3 months.
  11. Renal failure with a creatinine of ≥ 2,5 mg/dl, except patients currently on regular dialysis.
  12. Phenprocoumon intake, except for patients who are treated for Arterial Fibrillation. For these patients Phenprocoumon treatment can be interrupted and re-started after treatment with Dual Antiplatelet Therapy for 4 weeks post procedure.
  13. Known allergy to contrast media used for angiography that cannot be controlled by pre-medication with steroids and/or antihistaminica.
  14. Allergy, intolerance or hypersensitivity to Paclitaxel or related compounds and/or to the delivery matrix n-Butyryl tri-n-hexyl citrate(BTHC).
  15. Co- morbid conditions limiting life expectancy ≤ 1 year.
  16. Patients that are under active treatment for cancer; Patients, who have been successfully treated for cancer in the past, can be included.
  17. Subject is participating in another clinical device trial where the primary endpoint has not yet been reached.
  18. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867736

Locations
Austria
Medical University of Graz
Graz, Austria
Belgium
Imelda Hospital
Bonheiden, Belgium
A.Z. Sint-Blasius
Dendermonde, Belgium
Germany
Universitäts-Herzzentrum Freiburg
Bad Krozingen, Germany
Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin, Germany
Parkkrankenhaus Leipzig Südost GmbH
Leipzig, Germany
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Thomas Zeller, MD Universitäts-Herzzentrum Freiburg - Bad Krozingen, Germany
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01867736     History of Changes
Other Study ID Numbers: C1102
Study First Received: May 27, 2013
Last Updated: October 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Biotronik AG:
Stenosis
Occlusions
Infrapopliteal arteries
Below the knee arteries
PTA
POBA
DRB

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Dichlororibofuranosylbenzimidazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014