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| Name | Class |
|---|---|
| Straub Medical AG | INDUSTRY |
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Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atherectomy | Experimental | Atherectomy and drug-coated balloon (DCB) |
|
| Standard care | Active Comparator | Standard care with predilation (POBA) and DCB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atherectomy | Other | Straub Rotarex S atherectomy and drug-coated balloon DCB. Predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emerged Adverse Events | Incidence of Treatment-Emerged Adverse Events as assessed by angiography and adverse event assessment | 6 months Follow Up |
| Primary patency | determined through doppler ultrasound | 6 months Follow Up |
| Measure | Description | Time Frame |
|---|---|---|
| Bail-out stent rate | success of atherectomy in the SFA including the bail-out stenting rates | 6 months Follow Up |
| FMD local | Local endothelial function and vasomotion testing as determinded by FMD of the femoral artery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christos Rammos | Contact | 020172384808 | Christos.Rammos@uk-essen.de |
| Name | Affiliation | Role |
|---|---|---|
| Christos Rammos | Universität Duisburg-Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Essen | Recruiting | Essen | North Rhine-Westphalia | 45122 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36193630 | Derived | Rammos C, Manzke A, Lortz J, Messiha D, Petrikhovich O, Janosi RA, Steinmetz M, Rassaf T. Mechanical atherothrombectomy improves endothelial function through plaque burden reduction in PAD. Vasa. 2022 Nov;51(6):377-385. doi: 10.1024/0301-1526/a001034. Epub 2022 Oct 4. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017073 | Atherectomy |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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|
| POBA and DCB | Other | Standard predilation (POBA) and DCB. Predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA). |
|
| 6 months Follow Up |
| Vessel stiffness | Vascular stiffness determined through pulse wave velocity (PWV) | 6 months Follow Up |
| target lesion revascularization | freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization | 6 months Follow Up |
| ABI (Ankle Brachial Index) | Ankle Brachial Index assessed by Doppler | 6 months Follow Up |
| Systemic endothelial function | Change of endothelial function, assessed by the change in the vasodilation after reactive hyperaemia of the brachial artery (flow-mediated dilation = FMD) | 6 months Follow Up |
| Change in Plaque burden | Change in plaque burden is measured by plaque volume change using intravascular ultrasound (IVUS) | during baseline visit |
| Change in plaque characteristic | Change in plaque characteristic is quantified using virtual histology using intravascular ultrasound (IVUS) | during baseline visit |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |