STRAtiFy: SFA TReatment and vAscular Functions

Sponsor

University Hospital, Essen (Other)

Overall Status

Unknown status

CT.gov ID

NCT03811925

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Endovascular treatment of the superficial femoral artery has a high initial success rate, but restenosis occurs in up to 60% of cases. While restoration of tissue perfusion is achieved, interventional strategies affect endothelial function. Endothelial dysfunction is the pathophysiologic principle involved in the initiation and progression of arteriosclerosis.

The aim of this study is to determine the impact of endovascular strategies in the superficial femoral artery on local and systemic endothelial and vascular function.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Claudication, Intermittent	Procedure: Angioplasty and drug coated balloon of the superficial femoral artery (SFA) Procedure: Angioplasty and stenting of the superficial femoral artery (SFA)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Local and Systemic Vascular Function Following Drug Coated Balloon vs. Stenting in the Superficial Femoral Artery

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: DCB	Procedure: Angioplasty and drug coated balloon of the superficial femoral artery (SFA) In case of drug coated balloon (DCB) there should be always a 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)
Other: Stenting	Procedure: Angioplasty and stenting of the superficial femoral artery (SFA) In case of stent application there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). In case of stenting there should be a strong effect on vasomotion of the treated vessel area. All Stent lengths (40mm to 200 mm) and Diameters (5mm to 7mm) are eligible for the trial as long as used in the superficial femoral artery (SFA)

Arm

Intervention/Treatment

Other: DCB

Procedure: Angioplasty and drug coated balloon of the superficial femoral artery (SFA)

In case of drug coated balloon (DCB) there should be always a 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)

Other: Stenting

Procedure: Angioplasty and stenting of the superficial femoral artery (SFA)

In case of stent application there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). In case of stenting there should be a strong effect on vasomotion of the treated vessel area. All Stent lengths (40mm to 200 mm) and Diameters (5mm to 7mm) are eligible for the trial as long as used in the superficial femoral artery (SFA)

Outcome Measures

Primary Outcome Measures

local endothelial function [6 months Follow Up]
Change of endothelial function, assessed by the change in the vasodilatative reserve of the femoral artery (flow-mediated dilation = FMD)

Secondary Outcome Measures

Systemic endothelial function [6 months Follow Up]
1.Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Vessel stiffness [6 months Follow Up]
Vascular stiffness determined through pulse wave velocity (PWV)
Primary patency [6 months Follow Up]
determined through doppler ultrasound
target lesion revascularization [6 months Follow Up]
freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization
ABI (Ankle Brachial Index) [6 months Follow Up]
Ankle Brachial Index assessed by Doppler

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4, or 5
Planed peripheral intervention TASC A-C
Subject must be between 40 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
Guidewire must cross lesion(s) within the true lumen, without a relevant sub-intimal course
Vessel diameter ≥3.0 mm and ≤6.0 mm
Willing to comply with the specified follow-up evaluation
Written informed consent prior to any study procedures

Exclusion Criteria:

Lesions TASC D
Angiographic evidence of thrombus within target vessel
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Essen	Essen	NRW	Germany	45122

Sponsors and Collaborators

University Hospital, Essen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fadi Al-Rashid, Principal Investigator, University Hospital, Essen

ClinicalTrials.gov Identifier:

NCT03811925

Other Study ID Numbers:

STRAtiFy_CR

First Posted:

Jan 22, 2019

Last Update Posted:

Jan 22, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Intermittent Claudication

Study Results

No Results Posted as of Jan 22, 2019