BIOLUX P-I First in Man Study

B

Biotronik

Status

Completed

Conditions

Vascular Disease
Peripheral Artery Disease
Arteriosclerosis
Atherosclerosis

Treatments

Device: Standard PTA (POBA)
Device: Passeo-18 Lux DRB

Study type

Interventional

Funder types

Industry

Identifiers

NCT01221610
C1003

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment
  • Known allergy to contrast media that cannot be adequately controlled with pre-medication
  • Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)

Trial design

60 participants in 2 patient groups

Drug Releasing Balloon
Experimental group
Description:
Passeo-18 Lux Drug Releasing Balloon catheter
Treatment:
Device: Passeo-18 Lux DRB
Standard PT A (POBA)
Active Comparator group
Description:
Uncoated Passeo-18 PTA catheter
Treatment:
Device: Standard PTA (POBA)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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