Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon
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
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Consecutive patients intended to be or treated by the VITUS peripheral drug-coated dilatation catheter as per physicians' decision and according to IFU in the setting of routine clinical care are entered into the registry
* 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.
* If lesion is longer than the individual balloon, more than one DCB can be used for longer lesions with the mandatory overlapping balloons of 10mm to avoid any geographical miss.
* Rutherford clinical categories 2-5
Exclusion Criteria:
* The patients are excluded from registration if ANY of the following conditions apply:
* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
* Currently participating in another investigational drug or device study in which a routine angiographic follow-up in peripheral arteries is planned
* A life expectancy of \<1year
* Explicit refusal of participation in the registry
* Residual stenosis \>50% after vessel preparation
Primary outcome measure(s)
Proportion of participants with Adjudicated freedom from major adverse events (MAE) — 30 days post-procedure (primary safety endpoint at 30 days) 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)
Proportion of participants with Adjudicated freedom from major adverse events (MAE) — 12 months post-procedure (primary safety and efficacy endpoint at 12 months) 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
Occurrence of Adjudicated freedom from cd-TLR — 12 months post-procedure (primary 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
