Physician-Initiated Trial Investigating the Efficacy of Endovascular Treatment of Femoropopliteal Arterial Stenotic Disease With the Biotronik Passeo-18 Lux Drug Releasing Balloon and the Biotronik Pulsar-18 Stent (Comparing With 4EVER Trial Results)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02211664
• Date of registration: 06/08/2014
• Prospective Registration: No
• Primary sponsor: Flanders Medical Research Program
• Public title: Physician-Initiated Trial Investigating the Efficacy of Endovascular Treatment of Femoropopliteal Arterial Stenotic Disease With the Biotronik Passeo-18 Lux Drug Releasing Balloon and the Biotronik Pulsar-18 Stent (Comparing With 4EVER Trial Results) BIOLUX 4EVER
• Date of first enrolment: June 2014
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02211664
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

1. General Inclusion Criteria:

- De novo lesions located in the femoropopliteal arteries suitable for endovascular
treatment

- Patient presenting with a score from 2 to 4 according to the Rutherford
classification

- Patient is willing to comply with specified follow-up evaluations at the
predefined time intervals time

- Patients is >18 years old

- Patient understands the nature of the procedure and provides written informed
consent, prior to enrollment in the study

- Prior to enrollment, the target lesion was crossed with standard guidewire
manipulation

2. Angiographic Inclusion Criteria:

- The target lesions are located within the native SFA: distal point 3 cm above
knee joint and 1 cm below the origin of the profunda femoralis

- The target lesion has angiographic evidence of stenosis >50% or occlusion

- Length of the target lesion is = 19 cm by visual estimation and can be covered
with one stent

- Target vessel diameter visually estimated is =4 mm and =6 mm

- There is angiographic evidence of at least one-vessel-runoff to the foot

Exclusion Criteria:

- Presence of another stent in the target vessel that was placed during a previous
procedure

- Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis

- Previous bypass surgery in the same limb

- Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics

- Patients who exhibit persistent acute intraluminal thrombus at the target lesion site

- Perforation at the angioplasty site evidenced by extravasation of contrast medium

- Patients with known hypersensitivity to nickel-titanium

- Patients with uncorrected bleeding disorders

- Female patient with child bearing potential not taking adequate contraceptives or
currently breastfeeding

- Life expectancy of less than 12 months

- Ipsilateral iliac artery treatment before target lesion treatment with a residual
stenosis > 30%

- Use of thrombectomy, atherectomy or laser devices during procedure

- Any planned surgical intervention/procedure 30 days after the study procedure

- Any patient considered to be hemodynamically unstable at onset of procedure

- Patient is currently participating in another investigational drug or device study
that has not reached the primary endpoint



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Vascular Disease

Intervention(s)

Device: Pulsar-18 stent

Device: Passeo-18 balloon

Device: Passeo-18 Lux drug releasing balloon

Primary Outcome(s)

Primary patency at 12 months [Time Frame: 12 months]

Secondary Outcome(s)

Clinical success at 1-, 6-, 12- and 24-months follow-up [Time Frame: 1, 6, 12, 24 months]

Technical success [Time Frame: 1 day post-op]

Compression time [Time Frame: 1 day post-op]

Number of puncture site complications [Time Frame: 1 day post-op]

Changes in ABI measurements at 1-, 6-, 12- and 24-months [Time Frame: 1, 6, 12, 24 months]

Freedom from Target Lesion Revascularization (TLR) at at 1-, 6-, 12- and 24-months follow-up [Time Frame: 1, 6, 12 and 24 months]

Procedural success [Time Frame: 1 day post-op]

Primary patency rate at 1-month follow-up [Time Frame: 1 month]

Serious Adverse Events [Time Frame: up to 24 months]

Primary patency rate at 6- and 24-month follow-up [Time Frame: 6 and 24 months]

Secondary ID(s)

FMRP-120130

Source(s) of Monetary Support

Please refer to primary and secondary sponsors