NCT03052296

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

2.6 years

First QC Date

February 2, 2017

Last Update Submit

August 4, 2021

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

  • Freedom from Major Adverse Events (MAE)

    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)

    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 Outcomes (12)

  • Freedom from clinically-driven target lesion revascularization (TLR)

    6 months

  • Freedom from clinically-driven target vessel revascularization (TVR)

    6 and 12 months

  • Primary Patency

    12 months

  • Freedom from MAE

    12 months

  • Change in mean Ankle Brachial Index (ABI)

    6 and 12 months

  • +7 more secondary outcomes

Interventions

Passeo-18 Lux DCBDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Mataró

Barcelona, Spain

Location

Hospital San Cecilio

Granada, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, Spain

Location

Hospital Virgen de la Macarena

Seville, Spain

Location

Hospital Clínico Lozano Blesa Zaragoza

Zaragoza, Spain

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Miguel Angel de Gregorio

    Hospital Clínico and University of Zaragoza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 14, 2017

Study Start

March 22, 2017

Primary Completion

November 5, 2019

Study Completion

November 5, 2019

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(5)