BIOLUX P-III SPAIN All-Comers Registry

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: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Passeo-18 Lux DCB

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from clinically-driven target lesion revascularization (TLR)		6 months
Freedom from clinically-driven target vessel revascularization (TVR)		6 and 12 months
Primary Patency	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	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)	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		6 and 12 months
Amputation-free survival (AFS) including major, minor and overall AFS		6 and 12 months
Pain score compared to the pre-procedure score		6 and 12 months
Walking Impairment Questionnaire compared to the pre-procedure score		6 and 12 months
Device success	Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB.	Immediately upon procedure
Technical success	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	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

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Miguel Angel de Gregorio, Hospital Clínico and University of Zaragoza

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2017
• Primary Completion (ACTUAL): November 5, 2019
• Study Completion (ACTUAL): November 5, 2019

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (ACTUAL): February 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID 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