Safety and Efficacy of Atherectomy on VasculaR Functions

NCT04092972 | Unknown

• 1 other identifier: SAVioR_CR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Claudication, Intermittent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Bail-out stent rate

  6 months Follow Up

• FMD local

  6 months Follow Up

• Vessel stiffness

  6 months Follow Up

• target lesion revascularization

  6 months Follow Up

• ABI (Ankle Brachial Index)

  6 months Follow Up

Study Arms (2)

Atherectomy

EXPERIMENTAL

Atherectomy and drug-coated balloon (DCB)

Other: Atherectomy

Standard care

ACTIVE COMPARATOR

Standard care with predilation (POBA) and DCB

Other: POBA and DCB

Interventions

Atherectomy OTHER

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).

Atherectomy

POBA and DCB OTHER

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).

Standard care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead
• Straub Medical AG: collaborator

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 36193630 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Christos Rammos

  Universität Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Rammos

CONTACT

020172384808; Christos.Rammos@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: September 17, 2019
• Study Start: January 1, 2019
• Primary Completion: July 28, 2021
• Study Completion: August 31, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)