Peripheral Arterial Disease
Conditions
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
Interventions
DEVICEPasseo-18 Lux DCB
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)
Sponsors
Biotronik AG
Study design
Observational model
COHORT
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 (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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Major Adverse Events (MAE) | 6 months | 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) |
| Freedom from clinically driven target lesion revascularization (cd-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
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12 and 24 months | 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 |
| Freedom from Major Adverse Events (MAE) | 12 and 24 months | 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) |
| Change in mean Ankle Brachial Index (ABI) | 6, 12 and 24 months | compared to the pre-procedure |
| Improvement in Rutherford classification | 6, 12 and 24 months | compared to the pre-procedure Rutherford classification |
| Amputation-free survival (AFS) | 6, 12 and 24 months | including major, minor and overall AFS |
| Freedom from clinically-driven target lesion revascularization (cd-TLR) | 6 and 24 months | — |
| Walking Impairment Questionnaire | 6, 12 and 24 months | compared to the pre-procedure score. |
| Device success | immediately upon index procedure | Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB |
| Technical success | immediately upon index 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 |
| 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 |
| Pain score | 6, 12 and 24 months | compared to the pre-procedure score. |
| Freedom from clinically-driven target vessel revascularization (TVR) | 6, 12 and 24 months | — |
Countries
Belgium, Luxembourg, Netherlands
Outcome results
None listed