Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

Peripheral Arterial Disease Clinical Trial

Official title:

Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450042
• Other study ID #: The Limus FLOW Study
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: April 6, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Essen
• Contact: Christos Rammos, Professor
• Phone: 0201-723-84808
• Email: christos.rammos[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 6, 2024
• Est. primary completion date: April 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Eluting Balloon
• Flow-mediated Dilation
• Infrainguinal Peripheral Arterial Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• SELUTION SLR DCB
Sirolimus DCB
• Paclitaxel DCB
Paclitaxel DCB

Locations

Country	Name	City	State
Germany	University of Essen, Clinic of Cardiology and Angiology	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure	FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery	1 month
Primary	Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure	FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery	6 months
Primary	Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure	FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery	12 months
Secondary	Changes in pulse wave velocity (PWV)	Changes in cardiovascular function measured by pulse wave velocity in m/s	Baseline, followed at 1, 6 and 12 months
Secondary	Changes in augmentation index	Changes in cardiovascular function measured by augmentation index in %	Baseline, followed at 1, 6 and 12 months
Secondary	Changes in vascular strain	Changes in cardiovascular function measured by vascular strain in %	Baseline, followed at 1, 6 and 12 months
Secondary	Changes in peripheral perfusion determined by ABI (ankle brachial index)	ABI measurements are conducted using a Doppler probe on tibial and anterior artery locations. The highest value will be used for calculation and divided by the highest systolic brachial Doppler pressure	Baseline, followed at 1, 6 and 12 months
Secondary	Primary patency (PP) of target lesion	Primary patency determined by PVR measurement with ultrasound	Baseline, followed at 1, 6 and 12 months
Secondary	Changes in clinical symptoms	Clinical symptoms of patients determined by Walking impairment questionaire (WIQ)	Baseline, followed at 1, 6 and 12 months
Secondary	Changes in six-minute walk test	Six-minute walk test determined by pain-free walking distance in m	Baseline, followed at 1, 6 and 12 months
Secondary	Procedural complications	Any procedural complications	Baseline, followed at 1, 6 and 12 months
Secondary	Freedom from Target Lesion Revascularization	Freedom from Target Lesion Revascularization (FTLR)	Baseline, followed at 1, 6 and 12 months
Secondary	MALE	Any unplanned vascular event and minor or major amputations	Baseline, followed at 1, 6 and 12 months
Secondary	Changes of inflammatory profile measured by hs-CRP in mg/dl	Blood samples are collected at the below mentioned time points	Baseline, followed at 1, 6 and 12 months
Secondary	Changes of inflammatory profile measured by oxLDL in µg/l	Blood samples are collected at the below mentioned time points	Baseline, followed at 1, 6 and 12 months
Secondary	Changes of inflammatory profile measured by Interleukin-6 in pg/ml	Blood samples are collected at the below mentioned time points	Baseline, followed at 1, 6 and 12 months