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SFA TReatment and vAscular Functions (STRAtiFy)

Primary Purpose

Peripheral Arterial Disease, Claudication, Intermittent

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

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

Angioplasty and stenting of the superficial femoral artery (SFA)

About this trial

This is an interventional basic science trial for Peripheral Arterial Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University Hospital EssenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

DCB

Stenting

Arm Description

Outcomes

Primary Outcome Measures

local endothelial function

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

1.Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)

Vessel stiffness

Vascular stiffness determined through pulse wave velocity (PWV)

Primary patency

determined through doppler ultrasound

target lesion revascularization

freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization

ABI (Ankle Brachial Index)

Ankle Brachial Index assessed by Doppler

Full Information

NCT ID

NCT03811925

First Posted

January 16, 2019

Last Updated

January 17, 2019

Sponsor

University Hospital, Essen

1. Study Identification

Unique Protocol Identification Number

NCT03811925

Brief Title

SFA TReatment and vAscular Functions

Acronym

STRAtiFy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

June 1, 2019 (Anticipated)

Study Completion Date

July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Essen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease, Claudication, Intermittent

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DCB

Arm Type

Other

Arm Title

Stenting

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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)

Intervention Type

Procedure

Intervention Name(s)

Angioplasty and stenting of the superficial femoral artery (SFA)

Intervention Description

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)

Primary Outcome Measure Information:

Title

local endothelial function

Description

Change of endothelial function, assessed by the change in the vasodilatative reserve of the femoral artery (flow-mediated dilation = FMD)

Time Frame

6 months Follow Up

Secondary Outcome Measure Information:

Title

Systemic endothelial function

Description

1.Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)

Time Frame

6 months Follow Up

Title

Vessel stiffness

Description

Vascular stiffness determined through pulse wave velocity (PWV)

Time Frame

6 months Follow Up

Title

Primary patency

Description

determined through doppler ultrasound

Time Frame

6 months Follow Up

Title

target lesion revascularization

Description

freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization

Time Frame

6 months Follow Up

Title

ABI (Ankle Brachial Index)

Description

Ankle Brachial Index assessed by Doppler

Time Frame

6 months Follow Up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christos Rammos, MD

Phone

020172384808

Christos.Rammos@uk-essen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Christos Rammos

Phone

020172384808

Christos.Rammos@uk-essen.de

Facility Information:

Facility Name

University Hospital Essen

City

Essen

State/Province

NRW

ZIP/Postal Code

45122

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fadi Al-Rashid, Dr.med.

Phone

00492017230

fadi.al-rashid@uk-essen.de

First Name & Middle Initial & Last Name & Degree

Christos Rammos, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD

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