Clinical trial NCT05450042: Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
Official title: Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Flow-mediated Dilation
Drug Eluting Balloon
Infrainguinal Peripheral Arterial Disease
Keywords: Paclitaxel eluting ballon
Sirolimus eluting ballon
Percutaneous transluminal angioplasty
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
timeFrame: 1 month
measure: Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
timeFrame: 6 months
measure: Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
timeFrame: 12 months
Secondary outcomes:
measure: Changes in pulse wave velocity (PWV)
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Changes in augmentation index
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Changes in vascular strain
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Changes in peripheral perfusion determined by ABI (ankle brachial index)
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Primary patency (PP) of target lesion
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Changes in clinical symptoms
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Changes in six-minute walk test
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Procedural complications
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Freedom from Target Lesion Revascularization
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: MALE
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Changes of inflammatory profile measured by hs-CRP in mg/dl
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Changes of inflammatory profile measured by oxLDL in µg/l
timeFrame: Baseline, followed at 1, 6 and 12 months
measure: Changes of inflammatory profile measured by Interleukin-6 in pg/ml
timeFrame: Baseline, followed at 1, 6 and 12 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University of Essen, Clinic of Cardiology and Angiology
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Christos Rammos, Professor
role: PRINCIPAL_INVESTIGATOR
References: