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Completed

NCT Number: NCT03052296

BIOLUX P-III SPAIN All-Comers Registry

The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily clinical practice

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Mataró, Barcelona, Spain

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Who can participate

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 (PDRF) or Patient Informed Consent (PIC) where applicable
  • Subject classified as Rutherford class 4, 5 or 6
  • TASC C or D lesion(s) in the femoropopliteal artery
  • Lesion length > 15 cm 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 its primary endpoint yet.
  • Subject is pregnant or planning to become pregnant during the course of the study.
  • Rutherford class <4
  • 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).
  • Intraprocedural decision not to proceed with the Passeo18 Lux DCB for any reason not related to the device (for instance blood flow limiting dissection after predilatation).

Treatment and study plan

Passeo-18 Lux DCB

Device

The endovascular procedure is conducted as per the local standard practice and device instruction for use

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, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)

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

    Time frame: 12 months

    Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.)

Secondary outcomes

  1. Freedom from clinically-driven target lesion revascularization (TLR)

    Time frame: 6 months

  2. Freedom from clinically-driven target vessel revascularization (TVR)

    Time frame: 6 and 12 months

  3. Primary Patency

    Time frame: 12 months

    defined as freedom from >50% restenosis in the target lesion as indicated by a duplex ultrasound peak systolic velocity ratio (PSVR) >2.5 or by visual assessment of an angiogram with no clinically driven re-intervention.

  4. Freedom from MAE

    Time frame: 12 months

    Composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven TLR

  5. Change in mean Ankle Brachial Index (ABI)

    Time frame: 6 and 12 months

    Thigh or toe brachial index (TBI) may be used / performed if ABI is inadequate

  6. Improvement in Rutherford classification compared to the pre-procedure Rutherford classification

    Time frame: 6 and 12 months

  7. Amputation-free survival (AFS) including major, minor and overall AFS

    Time frame: 6 and 12 months

  8. Pain score compared to the pre-procedure score

    Time frame: 6 and 12 months

  9. Walking Impairment Questionnaire compared to the pre-procedure score

    Time frame: 6 and 12 months

  10. Device success

    Time frame: Immediately upon procedure

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

  11. Technical success

    Time frame: Immediately upon procedure

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

  12. Procedural success

    Time frame: Immediately upon discharge

    Procedural success is technical and device success without the occurrence of any MAE (as defined in the protocol) during the hospital stay

Sponsors and collaborators

Lead sponsor

Biotronik AG

Industry

Registry information

Official study title

BIOTRONIK - A Prospective, National, Multi-centre, Post-market Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Long Femoropopliteal Artery Lesions - III SPAIN

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 14, 2017
Registry last updated
Aug 5, 2021

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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