Safety and Efficacy of Atherectomy on VasculaR Functions

Peripheral Arterial Disease Clinical Trial

— SAVioR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092972
• Other study ID #: SAVioR_CR
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: January 2021
• Source: University Hospital, Essen
• Contact: Christos Rammos
• Phone: 020172384808
• Email: Christos.Rammos[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Claudication, Intermittent
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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).
• 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).

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Essen	Straub Medical AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Emerged Adverse Events	Incidence of Treatment-Emerged Adverse Events as assessed by angiography and adverse event assessment	6 months Follow Up
Primary	Primary patency	determined through doppler ultrasound	6 months Follow Up
Secondary	Bail-out stent rate	success of atherectomy in the SFA including the bail-out stenting rates	6 months Follow Up
Secondary	FMD local	Local endothelial function and vasomotion testing as determinded by FMD of the femoral artery	6 months Follow Up
Secondary	Vessel stiffness	Vascular stiffness determined through pulse wave velocity (PWV)	6 months Follow Up
Secondary	target lesion revascularization	freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization	6 months Follow Up
Secondary	ABI (Ankle Brachial Index)	Ankle Brachial Index assessed by Doppler	6 months Follow Up
Secondary	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
Secondary	Change in Plaque burden	Change in plaque burden is measured by plaque volume change using intravascular ultrasound (IVUS)	during baseline visit
Secondary	Change in plaque characteristic	Change in plaque characteristic is quantified using virtual histology using intravascular ultrasound (IVUS)	during baseline visit