Clinical trial NCT04092972: Safety and Efficacy of Atherectomy on VasculaR Functions
Official title: Safety and Efficacy of Interventional Treatment Through Atherectomy to Improve Vascular Functions and Patency in Symptomatic Peripheral Artery Disease - Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Claudication, Intermittent
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: Straub Medical AG
First posted: 2019-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Peripheral artery disease, lesions in the SFA and popliteal artery.
* Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, or 4
* 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 ≥3.0 mm and ≤7.0 mm
* Willing to comply with the specified follow-up evaluation
* Written informed consent prior to any study procedures

Exclusion Criteria:

* Thrombolysis within 72 hours prior to the index procedure
* Aneurysm 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
* Septicemia at the time of enrollment
* Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
* Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure

Primary outcomes:
measure: Treatment-Emerged Adverse Events
timeFrame: 6 months Follow Up
measure: Primary patency
timeFrame: 6 months Follow Up
Secondary outcomes:
measure: Bail-out stent rate
timeFrame: 6 months Follow Up
measure: FMD local
timeFrame: 6 months Follow Up
measure: Vessel stiffness
timeFrame: 6 months Follow Up
measure: target lesion revascularization
timeFrame: 6 months Follow Up
measure: ABI (Ankle Brachial Index)
timeFrame: 6 months Follow Up
measure: Systemic endothelial function
timeFrame: 6 months Follow Up
measure: Change in Plaque burden
timeFrame: during baseline visit
measure: Change in plaque characteristic
timeFrame: during baseline visit
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: Universität Duisburg-Essen
name: Christos Rammos
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.