- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811925
SFA TReatment and vAscular Functions (STRAtiFy)
Local and Systemic Vascular Function Following Drug Coated Balloon vs. Stenting in the Superficial Femoral Artery
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christos Rammos
- Phone Number: 020172384808
- Email: Christos.Rammos@uk-essen.de
Study Locations
-
-
NRW
-
Essen, NRW, Germany, 45122
- Recruiting
- University Hospital Essen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: DCB
|
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
local endothelial function
Time Frame: 6 months Follow Up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary patency
Time Frame: 6 months Follow Up
|
determined through doppler ultrasound
|
6 months Follow Up
|
Vessel stiffness
Time Frame: 6 months Follow Up
|
Vascular stiffness determined through pulse wave velocity (PWV)
|
6 months Follow Up
|
target lesion revascularization
Time Frame: 6 months Follow Up
|
freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization
|
6 months Follow Up
|
ABI (Ankle Brachial Index)
Time Frame: 6 months Follow Up
|
Ankle Brachial Index assessed by Doppler
|
6 months Follow Up
|
Systemic endothelial function
Time Frame: 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)
|
6 months Follow Up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STRAtiFy_CR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Disease
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
CID S.p.A.Meditrial Europe Ltd.Not yet recruitingPeripheral Arterial Occlusive Disease | Peripheral Artery DiseaseItaly
-
Marissa JarosinskiRecruitingPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Clopidogrel, Poor Metabolism of | Artery DiseaseUnited States
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Vascuros Medical Pte LtdNovella ClinicalUnknownPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery DiseaseSingapore, Belgium, Germany
-
Western Vascular Institute, IrelandRecruitingPeripheral Arterial Occlusive DiseaseIreland
-
Jena University HospitalAngioDroid s.r.l., Bologna (Italy)CompletedPeripheral Arterial Occlusive DiseaseGermany
-
Seoul National University HospitalAstellas Pharma Korea, Inc.CompletedPeripheral Arterial Occlusive DiseaseKorea, Republic of
-
Heidelberg UniversityTerminatedPeripheral Arterial Occlusive DiseaseGermany
-
Johann Wolfgang Goethe University HospitalSuspendedPeripheral Arterial Occlusive DiseaseGermany
Clinical Trials on Angioplasty and drug coated balloon of the superficial femoral artery (SFA)
-
IRCCS Policlinico S. DonatoActive, not recruitingAtherosclerosis | Stent ComplicationItaly
-
Jena University HospitalKKS Netzwerk; iVascular S.L.U.CompletedPeripheral Arterial DiseaseGermany
-
King Abdullah International Medical Research CenterTerminatedDysfunctional Dialysis Arteriovenous FistulaSaudi Arabia
-
Spectranetics CorporationCompletedPeripheral Artery DiseaseNew Zealand
-
Medtronic EndovascularCompletedPopliteal Artery Stenosis | Popliteal Artery Occlusion | Femoral Artery Occlusion | Femoral Artery StenosisUnited States
-
Texas Vascular AssociatesW.L.Gore & AssociatesCompletedAtherosclerosis | Claudication | Lower Extremity Ischemia | Rest PainUnited States
-
Julie DawsonActive, not recruitingIschaemic Heart DiseaseUnited Kingdom
-
St. Antonius HospitalUMC Utrecht; Albert Schweitzer Hospital; Amphia HospitalUnknownAtherosclerosis | Peripheral Arterial Occlusive DiseaseNetherlands
-
C. R. BardCompletedPopliteal Artery Stenosis | Popliteal Artery Occlusion | Femoral Artery Occlusion | Femoral Artery StenosisUnited States, Germany, Belgium, Austria
-
SurModics, Inc.CompletedPeripheral Arterial Disease | Peripheral Vascular DiseasesUnited States