Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

NCT ID: NCT05450042

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2024-04-06

Brief Summary

Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur.The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.

Detailed Description

Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur. While restoration of tissue perfusion is achieved, these interventional strategies affect vascular function, perpetuating dysfunctional vascular homeostasis. Vascular and endothelial dysfunction per se is the pathophysiologic principle involved in the initiation and progression of atherosclerosis and has been correlated to higher incidences of cardiac events such as myocardial infarction or the need for interventions. PTA and DCB treatment alter the endothelial homeostasis but the impact and detailed mechanisms are incompletely understood. The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis.

The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function.

Device to be used are SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (n = 35) vs. Active comparator, Paclitaxel eluting balloon (Medtronic InPact, n = 35)

The analysis of the primary end point will be performed on an intention-to-treat basis.

Subgroup analyses will be performed according to PAD classification etiology and based on stent length.

Conditions

Peripheral Arterial Disease; Flow-mediated Dilation; Drug Eluting Balloon; Infrainguinal Peripheral Arterial Disease

Keywords

Paclitaxel eluting ballon; Sirolimus eluting ballon; Percutaneous transluminal angioplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SELUTION SLR DCB

Sustained Limus Release drug eluting balloon

Group Type: EXPERIMENTAL

SELUTION SLR DCB

Intervention Type: DEVICE

Sirolimus DCB

Paclitaxel eluting balloon

Conventional: Medtronic INpact

Group Type: ACTIVE_COMPARATOR

Paclitaxel DCB

Intervention Type: DEVICE

Paclitaxel DCB

Interventions

SELUTION SLR DCB

Sirolimus DCB

Intervention Type: DEVICE

Paclitaxel DCB

Paclitaxel DCB

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Peripheral artery disease
• Target lesions 3 cm distal to the CFA-bifurcation including SFA and PA lesions
• Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
• 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 ≥4.0 mm and ≤7.0 mm
• Willing to comply with the specified follow-up evaluation
• Written informed consent prior to any study procedures
• Pretreatment with an adequately sized balloon

Exclusion Criteria

• Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement
• Instent-Restenosis
• Thrombolysis within 72 hours prior to the index procedure
• Aneurysm formations 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Chistos Rammos

Prof. Dr. med. C. Rammos, MD, FESC, MHBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christos Rammos, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

University of Essen, Clinic of Cardiology and Angiology

Essen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christos Rammos, Professor

Role: CONTACT

Phone: 0201-723-84808

Email: christos.rammos@uk-essen.de

Tienush Rassaf, Univ.-Prof.

Role: CONTACT

Phone: 0201-723-4801

Email: tienush.rassaf@uk-essen.de

Facility Contacts

Christos Rammos, Prof.

Role: primary

Tienush Rassaf, Univ.-Prof.

Role: backup

Other Identifiers

The Limus FLOW Study

Identifier Type: -

Identifier Source: org_study_id