BIOLUX P-III SPAIN All-Comers Registry

August 4, 2021 updated by: Biotronik AG

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Mataró
      • Granada, Spain
        • Hospital San Cecilio
      • Málaga, Spain
        • Hospital Regional Universitario de Málaga
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Zaragoza, Spain
        • Hospital Clínico Lozano Blesa Zaragoza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The BIOLUX P-III SPAIN registry will include subjects from an all-comers patient population with all subjects requiring revascularization of long femoropopliteal artery lesions with the Passeo-18 Lux DCB

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
6 months
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.)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from clinically-driven target lesion revascularization (TLR)
Time Frame: 6 months
6 months
Freedom from clinically-driven target vessel revascularization (TVR)
Time Frame: 6 and 12 months
6 and 12 months
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.
12 months
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
12 months
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 and 12 months
Improvement in Rutherford classification compared to the pre-procedure Rutherford classification
Time Frame: 6 and 12 months
6 and 12 months
Amputation-free survival (AFS) including major, minor and overall AFS
Time Frame: 6 and 12 months
6 and 12 months
Pain score compared to the pre-procedure score
Time Frame: 6 and 12 months
6 and 12 months
Walking Impairment Questionnaire compared to the pre-procedure score
Time Frame: 6 and 12 months
6 and 12 months
Device success
Time Frame: Immediately upon procedure
Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB.
Immediately upon procedure
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.
Immediately upon procedure
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
Immediately upon discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Miguel Angel de Gregorio, Hospital Clínico and University of Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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