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.

Study Overview

• Status: Completed
• Conditions: Arteriosclerosis; Atherosclerosis; Peripheral Artery Disease; Vascular Disease
• Intervention / Treatment: Device: Passeo-18 Lux DRB; Device: Standard PTA (POBA)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • AKH Wien, Kardiovaskuläre und Interventionelle Radiologie
• Germany
  • Bad Krozingen, Germany
    • Universitäts-Herzzentrum Freiburg Bad Krozingen
  • Berlin, Germany
    • Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge
  • Leipzig, Germany
    • Parkkrankenhaus Leipzig Südost GmbH
  • Rosenheim, Germany
    • Institut für diagnostische und interventionelle Radiologie, Klinikum Rosenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug Releasing Balloon; Passeo-18 Lux Drug Releasing Balloon catheter	Device: Passeo-18 Lux DRB; Other Names: Passeo-18 Lux Drug Releasing Balloon catheter
Active Comparator: Standard PT A (POBA); Uncoated Passeo-18 PTA catheter	Device: Standard PTA (POBA); Other Names: Passeo-18 PTA catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
6 months binary restenosis rate	6 months
6 months and 12 months TLR rate	6 and 12 months
6 months and 12 months change in mean ABI	6 and 12 months
6 months and 12 months change in Rutherford class	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)	6 and 12 months

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Dierk Scheinert, MD, Park-Krankenhaus Leipzig GmbH, Leipzig, Germany

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 15, 2010

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Stenosis; SFA; PTA; POBA; Occlusions; DRB
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Vascular Diseases; Peripheral Arterial Disease; Arteriosclerosis; Atherosclerosis
• Other Study ID Numbers: C1003