Peripheral Arterial DiseaseSTRAtiFyNCT03811925
SFA TReatment and vAscular Functions
A study testing Angioplasty and drug coated balloon of the superficial femoral artery (SFA) and Angioplasty and stenting of the superficial femoral artery (SFA) in people with Peripheral Arterial Disease and Claudication, Intermittent, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Claudication, Intermittent
- What is being tested?
- Angioplasty and drug coated balloon of the superficial femoral artery (SFA) and Angioplasty and stenting of the superficial femoral artery (SFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Essen
Essen, North Rhine-Westphalia, 45122
Fadi Al-Rashid, Dr.med., 00492017230, fadi.al-rashid@uk-essen.de
Christos Rammos, MD, PHD
About this study
Official title: 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.
- Being tested
- Angioplasty and drug coated balloon of the superficial femoral artery (SFA), Angioplasty and stenting of the superficial femoral artery (SFA)
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty and drug coated balloon of the superficial femoral artery (SFA)Procedure or surgery
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)
Angioplasty and stenting of the superficial femoral artery (SFA)Procedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| DCB | Other | Not described Receives: Procedure: Angioplasty and drug coated balloon of the superficial femoral artery (SFA) |
| Stenting | Other | Not described Receives: Procedure: Angioplasty and stenting of the superficial femoral artery (SFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
local endothelial function
Change of endothelial function, assessed by the change in the vasodilatative reserve of the femoral artery (flow-mediated dilation = FMD)
Measured: 6 months Follow Up
Secondary outcomes (5)
Systemic endothelial function
1.Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Measured: 6 months Follow Up
Vessel stiffness
Vascular stiffness determined through pulse wave velocity (PWV)
Measured: 6 months Follow Up
Primary patency
determined through doppler ultrasound
Measured: 6 months Follow Up
target lesion revascularization
freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization
Measured: 6 months Follow Up
ABI (Ankle Brachial Index)
Ankle Brachial Index assessed by Doppler
Measured: 6 months Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Jun 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadi Al-Rashid, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811925
- Sponsor's protocol ID
- STRAtiFy_CR
- Acronym
- STRAtiFy
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local and Systemic Vascular Function Following Drug Coated Balloon vs. Stenting in the Superficial Femoral Artery
- ClinicalTrials.gov ID
- NCT03811925
- Acronym / sponsor ID
- STRAtiFy / STRAtiFy_CR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | DCB |
| 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) | Procedure or surgery | Stenting |
Primary outcome
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)
5 secondary outcomes
Systemic endothelial function
Time frame: 6 months Follow Up
Vessel stiffness
Time frame: 6 months Follow Up
Primary patency
Time frame: 6 months Follow Up
target lesion revascularization
Time frame: 6 months Follow Up
ABI (Ankle Brachial Index)
Time frame: 6 months Follow Up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angioplasty and drug coated balloon of the superficial femoral artery (SFA) and Angioplasty and stenting of the superficial femoral artery (SFA) in people with Peripheral Arterial Disease and Claudication, Intermittent, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christos Rammos, MD (020172384808, Christos.Rammos@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local endothelial function (time frame: 6 months Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.