An observational study in Peripheral Arterial Disease and Peripheral Arterial Occlusive Disease, sponsored by OrbusNeich. Active, not recruiting at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by OrbusNeich · Observational
To collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (PAOD) intended to be or treated by the VITUS peripheral drug-coated dilatation catheter when used according to the Instructions for Use and treating physician decision. Data will be collected in order to assess the long-term safety and performance of the VITUS peripheral drug-coated dilatation catheter in routine clinical practice.
The multicenter, prospective registry population consists of consecutive patients with peripheral arterial occlusive disease (PAOD) who undergo percutaneous transluminal angioplasty (PTA) intervention and are intended to be or treated by the VITUS peripheral drug-coated dilatation catheter (according to the Instructions for Use) as part of routine clinical care. Approximately 284 patients from approximately 15 centers in Europe will be entered into the registry. Patients entered into the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.
A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.
Patients with symptomatic peripheral arterial disease
The lesion to be treated should be shorter than the nominal length of balloon at a reference vessel diameter of 2.0 mm up to 7.0 mm.
Exclusion Criteria:
The patients are excluded from registration if ANY of the following conditions apply:
The VITUS peripheral drug-coated dilatation catheter is indicated for use in patients with peripheral arterial occlusive disease (PAOD).
Device: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
Balloon angioplasty for the treatment of symptomatic peripheral arterial disease with a paclitaxel drug-coated balloon
Proportion of participants with Adjudicated freedom from major adverse events (MAE)
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)
Time frame: 30 days post-procedure (primary safety endpoint at 30 days)
Proportion of participants with Adjudicated freedom from major adverse events (MAE)
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
Time frame: 12 months post-procedure (primary safety and efficacy endpoint at 12 months)
Occurrence of Adjudicated freedom from cd-TLR
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
Time frame: 12 months post-procedure (primary efficacy endpoint at 12 months)
Proportion of participants with Adjudicated freedom from MAE
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 6 months
Time frame: 6 months
Occurrence of Adjudicated freedom from cd-TLR
Adjudicated freedom from clinically driven target lesion revascularization (cd-TLR)
Time frame: through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 24 months and 36 months
Occurrence of Adjudicated freedom from clinically driven target vessel revascularization (cd-TVR)
Adjudicated freedom from clinically driven target vessel revascularization (cd-TVR)
Time frame: through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months
Proportion of participants with Major amputation-free survival
Major amputation-free survival, defined as absence of target limb major amputation (above the ankle)
Time frame: through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months
Proportion of participants with Any amputation-free survival
Any amputation-free survival, defined as absence of any amputation in target limb
Time frame: through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months
Proportion of participants with Adjudicated freedom from MAE
Adjudicated freedom from MAE
Time frame: through hospital discharge (expected to be within 24 hours), 6 months, 12 months, 24 months and 36 months
Change in Rutherford clinical category
Mean change in rate from baseline Rutherford clinical category (clinical assessment at hospital visit)
Time frame: 12 months
Change in Walking Impairment Questionnaire (WIQ) results
Mean change in rate from baseline in Walking Impairment Questionnaire (WIQ) results (telephone interview questionnaire)
Time frame: 12 months, 24 months, and 36 months
Proportion of participants with Primary patency
Primary patency, defined as freedom from \>50% restenosis in the target lesion as indicated by a peak systolic velocity ratio \>2.4 on duplex ultrasound or by visual assessment of an angiogram (if patients visit hospital), or freedom from clinically-driven reintervention (if telephone contact)
Time frame: 12 months, 24 months, and 36 months
Proportion of participants with Device Success
Device Success: Successful reaching of the target lesion, inflation and deflation of the balloon catheter, and a final residual stenosis after DCB treatment of ≤30% by visual assessment
Time frame: Peri-procedural
Proportion of participants with Procedure Success
Procedure Success: Successful balloon delivery, deployment, and retrieval, with no peri-procedural death, or target vessel revascularization (TVR)
Time frame: Peri-procedural
Quality of Life Assessment
Mean change from baseline in European Quality of Life-5 Dimensions (EQ-5D) questionnaire The descriptive system assesses the quality of life and has one question for each of the five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These answers are combined and converted to an index with 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time frame: 12 months
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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