BIOLUX P-III SPAIN All-Comers Registry

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT03052296
• Lead Sponsor: Biotronik AG

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Study Start: 2017-03-22
• Primary Completion: 2019-11-05
• Study Completion: 2019-11-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from Major Adverse Events (MAE)	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)
Freedom from clinically driven Target Lesion Revascularization (TLR)	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.)

Secondary Outcome Measures

Name	Time	Method
Primary Patency	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.
Walking Impairment Questionnaire compared to the pre-procedure score	6 and 12 months
Device success	Immediately upon procedure	Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB.
Freedom from clinically-driven target lesion revascularization (TLR)	6 months
Freedom from MAE	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
Technical success	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.
Freedom from clinically-driven target vessel revascularization (TVR)	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
Improvement in Rutherford classification compared to the pre-procedure Rutherford classification	6 and 12 months
Procedural success	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
Change in mean Ankle Brachial Index (ABI)	6 and 12 months	Thigh or toe brachial index (TBI) may be used / performed if ABI is inadequate

Trial Locations

Locations (5)

Hospital Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Hospital Mataró; 🇪🇸 Barcelona, Spain

Hospital Clínico Lozano Blesa Zaragoza; 🇪🇸 Zaragoza, Spain

Hospital San Cecilio; 🇪🇸 Granada, Spain

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain