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Completed

NCT Number: NCT02276313

BIOLUX P-III All-Comers Passeo-18 Lux Registry

BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairns Hospital, Cairns, Australia

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About this study

The Passeo-18 LUX Paclitaxel Releasing BalloonCatheter is a novel drug-releasing balloon that received CE-mark in January 2014. Its safety and efficacy has been investigated in two randomized First-in-Man trials in patients with stenosis or occlusion of the femoropopliteal (BIOLUX P-I) and infrapopliteal (BIOLUX P-II) arteries when compared to an uncoated device.

The purpose of the BIOLUX P-III all-comers registry is to collect short and long-term clinical performance data on the Passeo-18 Lux DRB in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in daily clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years or minimum age as required by local regulations
  • Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
  • Lesion(s) in the infrainguinal arteries suitable for endovascular treatment treated with or scheduled to be treated with the Passeo-18 Lux drug releasing balloon

Exclusion criteria

  • Life expectancy ≤ 1 year
  • Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
  • Subject is pregnant or planning to become pregnant during the course of the study
  • Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations

Treatment and study plan

Passeo-18 Lux

Device

Endovascular Therapy

Primary outcomes

  1. Freedom from Major Adverse Events (MAE)

    Time frame: 6 months

    A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) within 6 months post-index procedure.

  2. Freedom from clinically-driven Target Lesion Revascularization (TLR)

    Time frame: 12 months

Secondary outcomes

  1. Freedom from clinically-driven TLR

    Time frame: 6 and 24 months

  2. Freedom from clinically-driven Target Vessel Revascularization (TVR)

    Time frame: 6 and 24 months

  3. Primary patency

    Time frame: 12 and 24 months

  4. Freedom from MAE

    Time frame: 12 and 24 months

  5. Change in mean Ankle Brachial Index

    Time frame: 6, 12 and 24 months

  6. Amputation-free survival

    Time frame: 6, 12 and 24 months

  7. Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire

    Time frame: 6, 12 and 24 months

  8. Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification

    Time frame: 6, 12 and 24 months

  9. Device success

    Time frame: Day 0

    Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB.

  10. Technical success

    Time frame: Day 0

    Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation

  11. Procedural success

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days

    Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay

Sponsors and collaborators

Lead sponsor

Biotronik AG

Industry

Registry information

Official study title

BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III

Important dates

Study start
2014
Primary completion
2018
Study completion
2022
First posted
Oct 28, 2014
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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