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| Name | Class |
|---|---|
| Eucatech AG | INDUSTRY |
| Centre Européen de Recherche Cardiovasculaire | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VITUS peripheral drug-coated dilatation catheter | The VITUS peripheral drug-coated dilatation catheter is indicated for use in patients with peripheral arterial occlusive disease (PAOD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Transluminal Angioplasty with a paclitaxel drug-coated balloon | Device | Balloon angioplasty for the treatment of symptomatic peripheral arterial disease with a paclitaxel drug-coated balloon |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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 | 12 months post-procedure (primary efficacy endpoint at 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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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.
Rutherford clinical categories 2-5
Exclusion Criteria:
The patients are excluded from registration if ANY of the following conditions apply:
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Patients with symptomatic peripheral arterial disease
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| Name | Affiliation | Role |
|---|---|---|
| Koen Deloose, MD | AZ St Blasius Dendermonde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZORG | Aalst | 9300 | Belgium | |||
| AZ Sint-Blasius |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| C564658 | Peripheral Arterial Occlusive Disease 1 |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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| Occurrence of Adjudicated freedom from cd-TLR |
Adjudicated freedom from clinically driven target lesion revascularization (cd-TLR) |
| 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) | 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) | 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 | 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 | 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) | 12 months |
| Change in Walking Impairment Questionnaire (WIQ) results | Mean change in rate from baseline in Walking Impairment Questionnaire (WIQ) results (telephone interview questionnaire) | 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) | 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 | 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) | 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). | 12 months |
| Dendermonde |
| 9200 |
| Belgium |
| ZOL Genk | Genk | 3600 | Belgium |
| AZ Groennge | Kortrijk | 3000 | Belgium |
| RZ Heilig Hart Tienen | Tienen | 3300 | Belgium |
| AZ Jan Portaels | Vilvoorde | 1800 | Belgium |
| Klinikum Lippe Detmold | Detmold | 32756 | Germany |
| SRH Klinikum Karlsbad-Langensteinbach GmbH | Karlsbad | 76307 | Germany |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Hospital Universitario de Cabueñes | Gijón | 33394 | Spain |
| Hospital General de Granollers | Granollers | 08402 | Spain |
| Complejo Hospitalario Universitario de Ourense | Ourense | 32005 | Spain |
| Hospital Universitario de Toledo | Toledo | 45007 | Spain |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |