Atherosclerosis, Peripheral Artery Disease
Conditions
Keywords
Peripheral, Infrainguinal, Drug Releasing Balloon, Drug Eluting Balloon
Brief summary
BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.
Detailed description
The Passeo-18 LUX Paclitaxel Releasing BalloonCatheter is a novel drug-releasing balloon that received CE-mark in January 2014. Its safety and efficacy has been investigated in two randomized First-in-Man trials in patients with stenosis or occlusion of the femoropopliteal (BIOLUX P-I) and infrapopliteal (BIOLUX P-II) arteries when compared to an uncoated device. The purpose of the BIOLUX P-III all-comers registry is to collect short and long-term clinical performance data on the Passeo-18 Lux DRB in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in daily clinical practice.
Interventions
DEVICEPasseo-18 Lux
Endovascular Therapy
Sponsors
Biotronik AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years or minimum age as required by local regulations * Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable * Lesion(s) in the infrainguinal arteries 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 ist primary endpoint yet * Subject is pregnant or planning to become pregnant during the course of the study * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Major Adverse Events (MAE) | 6 months | A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) within 6 months post-index procedure. |
| Freedom from clinically-driven Target Lesion Revascularization (TLR) | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12 and 24 months | — |
| Freedom from MAE | 12 and 24 months | — |
| Change in mean Ankle Brachial Index | 6, 12 and 24 months | — |
| Amputation-free survival | 6, 12 and 24 months | — |
| Freedom from clinically-driven TLR | 6 and 24 months | — |
| Clinical Success: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification | 6, 12 and 24 months | — |
| Device success | Day 0 | Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DRB. |
| Technical success | Day 0 | Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation |
| Procedural success | Participants will be followed for the duration of hospital stay, an expected average of 1-2 days | Procedural success is technical and device success without the occurrence of any major adverse events during the hospital stay |
| Patient-reported outcomes assessment: Pain score, Walking Impairment Questionnaire | 6, 12 and 24 months | — |
| Freedom from clinically-driven Target Vessel Revascularization (TVR) | 6 and 24 months | — |
Countries
Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Latvia, Malaysia, Netherlands, Portugal, Singapore, Slovakia, Spain, Switzerland
Outcome results
None listed