BIOLUX P-III BENELUX All-Comers Registry

NCT03052309 | Completed

• 1 other identifier: C1604
• Study Type: observational
• Target: 106
• Locations: 3 countries
• Sites: 9

Brief Summary

The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries

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

Interventions

Passeo-18 Lux DCB DEVICE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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
• Subject must be willing to sign a Patient Data Release Form (PDRF) or Patient Informed Consent (PIC) where applicable
• Lesion(s) in the popliteal arteries suitable for endovascular treatment, treated with or scheduled to be treated with the Passeo-18 Lux drug coated balloon.
• Isolated popliteal artery lesion: at least 2 cm of healthy segment between lesion(s) in the popliteal artery and lesion(s) in distal superficial femoral artery
• Inflow free from flow-limiting lesion. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion(s) have been treated successfully before or during the index procedure, with a maximum residual stenosis of 30% per visual assessment
• At least one native artery with direct outflow artery to the foot
• Rutherford classification 2-5
• Patient with bypass surgery in the same limb can be enrolled if there is at least 2 cm healthy segment between popliteal artery and anastomosis

You may not qualify if:

• Life expectancy ≤ 1 year
• Rutherford classification 6
• Lesion involving the superficial femoral artery (arterial intersection with the femur in an anteroposterior view) or extending in infra-popliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk)
• Aneurysm at the level of the popliteal artery
• 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)
• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (9)

Ziekenhuis Oost Limburg Genk

Genk, Belgium

Location

University Hospital Gent (UZ Gent)

Ghent, Belgium

Location

Algemeen Ziekenhuis Groeninge Kortrijk

Kortrijk, Belgium

Location

Algemeen Ziekenhuis Delta Roeselare

Roeselare, Belgium

Location

AZ Portaels

Vilvoorde, Belgium

Location

Centre Hospitaliers Luxembourg

Luxembourg, Luxembourg

Location

OLVG

Amsterdam, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Maxima Medisch Centrum Veldhoven

Veldhoven, Netherlands

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Franck Vermassen

  UZ Gent

  PRINCIPAL INVESTIGATOR

• JGAM Blomjous

  OLVG Amsterdam

  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: February 24, 2017
• Primary Completion: June 9, 2020
• Study Completion: April 27, 2021
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5); LU (1); NL (3)