Peripheral Arterial Disease, Flow-mediated Dilation, Drug Eluting Balloon, Infrainguinal Peripheral Arterial Disease
Conditions
Keywords
Paclitaxel eluting ballon, Sirolimus eluting ballon, Percutaneous transluminal angioplasty
Brief summary
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur.The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.
Detailed description
Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur. While restoration of tissue perfusion is achieved, these interventional strategies affect vascular function, perpetuating dysfunctional vascular homeostasis. Vascular and endothelial dysfunction per se is the pathophysiologic principle involved in the initiation and progression of atherosclerosis and has been correlated to higher incidences of cardiac events such as myocardial infarction or the need for interventions. PTA and DCB treatment alter the endothelial homeostasis but the impact and detailed mechanisms are incompletely understood. The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function. Device to be used are SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (n = 35) vs. Active comparator, Paclitaxel eluting balloon (Medtronic InPact, n = 35) The analysis of the primary end point will be performed on an intention-to-treat basis. Subgroup analyses will be performed according to PAD classification etiology and based on stent length.
Interventions
DEVICESELUTION SLR DCB
Sirolimus DCB
DEVICEPaclitaxel DCB
Paclitaxel DCB
Sponsors
University Hospital, Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Peripheral artery disease * Target lesions 3 cm distal to the CFA-bifurcation including SFA and PA lesions * Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5 * Planed peripheral intervention TASC A-D * Subject must be between 18 and 85 years old * Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation * Vessel diameter ≥4.0 mm and ≤7.0 mm * Willing to comply with the specified follow-up evaluation * Written informed consent prior to any study procedures * Pretreatment with an adequately sized balloon
Exclusion criteria
* Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement * Instent-Restenosis * Thrombolysis within 72 hours prior to the index procedure * Aneurysm formations in the femoral artery or popliteal artery * Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy * Unstable angina pectoris at the time of the enrollment * Recent myocardial infarction or stroke \< 30 days prior to the index procedure * Life expectancy less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure | 1 month | FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in augmentation index | Baseline, followed at 1, 6 and 12 months | Changes in cardiovascular function measured by augmentation index in % |
| Changes in vascular strain | Baseline, followed at 1, 6 and 12 months | Changes in cardiovascular function measured by vascular strain in % |
| Changes in peripheral perfusion determined by ABI (ankle brachial index) | Baseline, followed at 1, 6 and 12 months | ABI measurements are conducted using a Doppler probe on tibial and anterior artery locations. The highest value will be used for calculation and divided by the highest systolic brachial Doppler pressure |
| Primary patency (PP) of target lesion | Baseline, followed at 1, 6 and 12 months | Primary patency determined by PVR measurement with ultrasound |
| Changes in clinical symptoms | Baseline, followed at 1, 6 and 12 months | Clinical symptoms of patients determined by Walking impairment questionaire (WIQ) |
| Changes in six-minute walk test | Baseline, followed at 1, 6 and 12 months | Six-minute walk test determined by pain-free walking distance in m |
| Changes in pulse wave velocity (PWV) | Baseline, followed at 1, 6 and 12 months | Changes in cardiovascular function measured by pulse wave velocity in m/s |
| Freedom from Target Lesion Revascularization | Baseline, followed at 1, 6 and 12 months | Freedom from Target Lesion Revascularization (FTLR) |
| MALE | Baseline, followed at 1, 6 and 12 months | Any unplanned vascular event and minor or major amputations |
| Changes of inflammatory profile measured by hs-CRP in mg/dl | Baseline, followed at 1, 6 and 12 months | Blood samples are collected at the below mentioned time points |
| Changes of inflammatory profile measured by oxLDL in µg/l | Baseline, followed at 1, 6 and 12 months | Blood samples are collected at the below mentioned time points |
| Changes of inflammatory profile measured by Interleukin-6 in pg/ml | Baseline, followed at 1, 6 and 12 months | Blood samples are collected at the below mentioned time points |
| Procedural complications | Baseline, followed at 1, 6 and 12 months | Any procedural complications |
Countries
Germany
Contacts
Primary ContactChristos Rammos, Professor
Backup ContactTienush Rassaf, Univ.-Prof.
Outcome results
None listed