VITUS is a Single-arm, Prospective, Open Label, All Comers, Multicenter Registry of paclitaxel drug-coated balloon angioplasty for the treatment of symptomatic peripheral arterial disease to assess the safety and performance of a paclitaxel drug-coated balloon for the treatment of peripheral arterial occlusive disease.
Sponsor
Eucatech AG which is owned by OrbusNeich Medical Company Limited
Study objectives
The objective is to enroll 284 diabetic patients with peripheral arterial occlusive disease who will be followed up at Immediate post-op, 30 days, 6 months, 12 months, 24 months and at 36 months.
Primary endpoints
- Adjudicated freedom from major adverse events (MAE), where MAE is defined as a composite of device- and procedure-related mortality, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (cd-TLR) at 30 days (primary safety endpoint at 30 days)
- Adjudicated freedom from MAE, where MAE is defined as a composite of device- and procedure-related mortality through 30 days, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (cd-TLR) within 12 months (primary safety and efficacy endpoint at 12 months)
- Adjudicated freedom from cd-TLR, where cd-TLR is defined as any reintervention performed for ≥50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms, at 12 months (primary efficacy endpoint at 12 months)
CERC Services
- Clinical report
- Clinical trial documentation
- CoreLab activities
- Monitoring activities
- Project management
- Regulatory submissions
- Safety reporting
- Set-up activities (sites selection, insurance management, contract management)
Countries
Around 4 countries across Europe and Asia.
Europe: Belgium, Germany and Spain.
Asia: Singapore.
Number of investigational sites
15
