SFA TReatment and vAscular Functions

NCT03811925 | Unknown

• 1 other identifier: STRAtiFy_CR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Claudication, Intermittent

Outcome Measures

Primary Outcomes (1)

• local endothelial function

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

  6 months Follow Up

Secondary Outcomes (5)

• Systemic endothelial function

  6 months Follow Up

• Vessel stiffness

  6 months Follow Up

• Primary patency

  6 months Follow Up

• target lesion revascularization

  6 months Follow Up

• ABI (Ankle Brachial Index)

  6 months Follow Up

Study Arms (2)

DCB

OTHER

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

Stenting

OTHER

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

Interventions

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

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)

DCB

Angioplasty and stenting of the superficial femoral artery (SFA) PROCEDURE

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)

Stenting

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Christos Rammos, MD

CONTACT

020172384808; Christos.Rammos@uk-essen.de

Christos Rammos

CONTACT

020172384808; Christos.Rammos@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 22, 2019
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)