VITUS Post-Market Registry

Not yet recruiting

• Conditions: Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease

• Registration Number: NCT06832631
• Lead Sponsor: OrbusNeich

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Study Start: 2025-04
• Primary Completion: 2027-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 284

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with Adjudicated freedom from MAE	through hospital discharge (expected to be within 24 hours), 6 months, 12 months, 24 months and 36 months	Adjudicated freedom from MAE
Occurrence of Adjudicated freedom from cd-TLR	through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 24 months and 36 months	Adjudicated freedom from clinically driven target lesion revascularization (cd-TLR)
Occurrence of Adjudicated freedom from clinically driven target vessel revascularization (cd-TVR)	through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months	Adjudicated freedom from clinically driven target vessel revascularization (cd-TVR)
Proportion of participants with Major amputation-free survival	through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months	Major amputation-free survival, defined as absence of target limb major amputation (above the ankle)
Proportion of participants with Any amputation-free survival	through hospital discharge (expected to be within 24 hours), at 30 days, 6 months, 12 months, 24 months and 36 months	Any amputation-free survival, defined as absence of any amputation in target limb
Change in Rutherford clinical category	12 months	Mean change in rate from baseline Rutherford clinical category (clinical assessment at hospital visit)
Change in Walking Impairment Questionnaire (WIQ) results	12 months, 24 months, and 36 months	Mean change in rate from baseline in Walking Impairment Questionnaire (WIQ) results (telephone interview questionnaire)
Proportion of participants with Primary patency	12 months, 24 months, and 36 months	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)
Proportion of participants with Device Success	Peri-procedural	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
Proportion of participants with Procedure Success	Peri-procedural	Procedure Success: Successful balloon delivery, deployment, and retrieval, with no peri-procedural death, or target vessel revascularization (TVR)
Quality of Life Assessment	12 months	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).