VITUS Post-Market Registry

OrbusNeich

Status: Enrolling

Conditions: Peripheral Arterial Occlusive Disease; Peripheral Arterial Disease

Treatments: Device: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06832631

DVAL-PLAN-064

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 284 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

284 participants in 1 patient group

VITUS peripheral drug-coated dilatation catheter

Description:

The VITUS peripheral drug-coated dilatation catheter is indicated for use in patients with peripheral arterial occlusive disease (PAOD).

Treatment:

Device: Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon