BIOLUX P-I First in Man Study

NCT01221610 | Completed DMC

• 1 other identifier: C1003
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Atherosclerosis; Arteriosclerosis; Vascular Disease; Peripheral Artery Disease

Keywords

Stenosis; Occlusions; SFA; PTA; POBA; DRB

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Drug Releasing Balloon

EXPERIMENTAL

Passeo-18 Lux Drug Releasing Balloon catheter

Device: Passeo-18 Lux DRB

Standard PT A (POBA)

ACTIVE COMPARATOR

Uncoated Passeo-18 PTA catheter

Device: Standard PTA (POBA)

Interventions

Passeo-18 Lux DRB DEVICE

Also known as: Passeo-18 Lux Drug Releasing Balloon catheter

Drug Releasing Balloon

Standard PTA (POBA) DEVICE

Also known as: Passeo-18 PTA catheter

Standard PT A (POBA)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years,
• Informed consent signed by patient prior to randomization
• Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
• Rutherford Class 2 - 5 in the target limb
• Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
• 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
• At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
• Successful wire crossing of the lesion
• Willingness to comply with all specified follow-up evaluations
• Male or negative pregnancy test of women in childbearing age

You may not qualify if:

• Co-morbid conditions limiting life expectancy ≤ 1 year
• Patient currently participating in another clinical trial
• Lesions which are untreatable with PTA or other interventional techniques
• 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
• Thrombus in the target vessel, documented by angiography
• Target lesion is severely calcified, documented by angiography
• Prior bypass surgery of target vessel
• Previously implanted stent in the target lesion
• Treatment of bifurcation required
• Planned amputation of the target limb
• Flow-limiting (\> 50% DS) Inflow lesion proximal to target lesion, left untreated
• 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)
• 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 %
• 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
• Phenprocoumon intake

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (5)

AKH Wien, Kardiovaskuläre und Interventionelle Radiologie

Vienna, Austria

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, Germany

Location

Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge

Berlin, Germany

Location

Parkkrankenhaus Leipzig Südost GmbH

Leipzig, Germany

Location

Institut für diagnostische und interventionelle Radiologie, Klinikum Rosenheim

Rosenheim, Germany

Location

MeSH Terms

Conditions

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Peripheral Arterial Disease; Constriction, Pathologic; Bites and Stings

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Dierk Scheinert, MD

  Park-Krankenhaus Leipzig GmbH, Leipzig, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 15, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

DE (4); AU (1)