Safety and Efficacy of Atherectomy on VasculaR Functions (SAVioR)

Safety and Efficacy of Interventional Treatment Through Atherectomy to Improve Vascular Functions and Patency in Symptomatic Peripheral Artery Disease - Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Claudication, Intermittent
• Intervention / Treatment: Other: Atherectomy; Other: POBA and DCB

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christos Rammos; Phone Number: 020172384808; Email: Christos.Rammos@uk-essen.de

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45122
      • Recruiting
      • University Hospital Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Atherectomy; Atherectomy and drug-coated balloon (DCB)	Other: Atherectomy; 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).
ACTIVE_COMPARATOR: Standard care; Standard care with predilation (POBA) and DCB	Other: POBA and DCB; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Collaborators: Straub Medical AG
• Investigators: Principal Investigator: Christos Rammos, Universität Duisburg-Essen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): July 28, 2021
• Study Completion (ANTICIPATED): August 31, 2021

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: September 15, 2019
• First Posted (ACTUAL): September 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: SAVioR_CR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No