Safety and Efficacy of Atherectomy on VasculaR Functions

NCT ID: NCT04092972

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Atherectomy

Atherectomy and drug-coated balloon (DCB)

Group Type: EXPERIMENTAL

Atherectomy

Intervention Type: 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).

Standard care

Standard care with predilation (POBA) and DCB

Group Type: ACTIVE_COMPARATOR

POBA and DCB

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Straub Medical AG

INDUSTRY

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Fadi Al-Rashid

MD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christos Rammos

Role: PRINCIPAL_INVESTIGATOR

Universität Duisburg-Essen

Locations

University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christos Rammos

Role: CONTACT

Christos.Rammos@uk-essen.de

020172384808

Facility Contacts

Fadi Al-Rashid, Dr.med.

Role: primary

fadi.al-rashid@uk-essen.de

00492017230

References

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.

Reference Type: DERIVED

PMID: 36193630 (View on PubMed)

Other Identifiers

SAVioR_CR

Identifier Type: -

Identifier Source: org_study_id