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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276313
Recruitment Status : Unknown
Verified May 2018 by Biotronik AG.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Brief Summary:
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.

Condition or disease Intervention/treatment
Atherosclerosis Peripheral Artery Disease Device: Passeo-18 Lux

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 880 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Actual Study Start Date : October 2014
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : February 2019

Intervention Details:
  • Device: Passeo-18 Lux
    Endovascular Therapy


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects from an all-comers patient population with all subjects requiring infrainguinal revascularization with the Passeo-18 Lux DRB.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276313


Locations
Show Show 45 study locations
Sponsors and Collaborators
Biotronik AG
Investigators
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Principal Investigator: Gunnar Tepe, MD RoMed Klinikum Rosenheim
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT02276313    
Other Study ID Numbers: C1211
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Keywords provided by Biotronik AG:
Peripheral
Infrainguinal
Drug Releasing Balloon
Drug Eluting Balloon
Additional relevant MeSH terms:
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Atherosclerosis
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases