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This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart Stent in the Superficial Femoral Artery . | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Registry | Procedure | A Registry will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patency as defined by absence of occlusion or >50% restenosis rate at the level the treated lesion as determined by duplex control. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patency as defined by absence of occlusion, whether or not after additional intervention to maintain this patency (primary and secondary patency rate) | 1 year | |
| Target lesion revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis at the level of the stented lesion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Vermassen, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Website of the University Hospital Ghent | View source |
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| 1 year |
| Target vessel revascularisation rate as defined by the number of new revascularisations (endovascular or open) carried out due to restenosis or a new stenosis in the SFA. | 1 year |
| Limbs-salvage rate | 1 year |
| Clinical success rate defined on improvement in symptoms according to the Rutherford classification by a minimum of 1 class. | 1 year |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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