Trials Sponsors Conditions Drugs Pricing

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

Freedom from Major Adverse Events (MAE)
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 (cd-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 (cd-TLR)
6 and 24 months
Freedom from clinically-driven target vessel revascularization (TVR)
6, 12 and 24 months
Primary patency
12 and 24 months
Freedom from Major Adverse Events (MAE)
12 and 24 months
Change in mean Ankle Brachial Index (ABI)
6, 12 and 24 months
+7 more secondary outcomes

Interventions

Passeo-18 Lux DCBDevice

The decision to treat the patient with Passeo-18 DCB is at the investigator discretion. The endovascular procedure is performed as per standard of care and device Instructions For Use (IFU)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

The BIOLUX P-III BENELUX registry will include subjects from an all-comers patient population with all subjects requiring popliteal artery revascularization with the Passeo-18 Lux DCB

You may qualify if:

Age ≥ 18 years or minimum age as required by local regulations

Sponsors & Collaborators

Biotronik AG
Industrylead

Study Sites (9)

Ziekenhuis Oost Limburg Genk

Genk, Belgium

University Hospital Gent (UZ Gent)

Ghent, Belgium

Algemeen Ziekenhuis Groeninge Kortrijk

Kortrijk, Belgium

Algemeen Ziekenhuis Delta Roeselare

Roeselare, Belgium

AZ Portaels

Vilvoorde, Belgium

Centre Hospitaliers Luxembourg

Luxembourg, Luxembourg

OLVG

Amsterdam, Netherlands

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

Franck Vermassen
UZ Gent
PRINCIPAL INVESTIGATOR
JGAM Blomjous
OLVG Amsterdam
PRINCIPAL INVESTIGATOR

Enrollment

106 participants (actual enrollment reported by the registry).

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

February 24, 2017

Actual (reported)

BIOLUX P-III BENELUX All-Comers Registry

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations