Peripheral Arterial DiseaseSAVioRNCT04092972
Safety and Efficacy of Atherectomy on VasculaR Functions
A study testing Atherectomy and POBA and DCB in people with Peripheral Arterial Disease and Claudication, Intermittent, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Claudication, Intermittent
- What is being tested?
- Atherectomy and POBA and DCB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 31 Aug 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral artery disease, lesions in the SFA and popliteal artery.
- Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, or 4
- Planed peripheral intervention TASC A-D
- Subject must be between 18 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
- Vessel diameter ≥3.0 mm and ≤7.0 mm
- Willing to comply with the specified follow-up evaluation
- Written informed consent prior to any study procedures
Who cannot join
- 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
Show all 9Show fewer
- 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: Safety and Efficacy of Interventional Treatment Through Atherectomy to Improve Vascular Functions and Patency in Symptomatic Peripheral Artery Disease - Pilot Study
Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.
- Being tested
- Atherectomy, POBA and DCB
- 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.
AtherectomyOther
Straub Rotarex S atherectomy and drug-coated balloon DCB. 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).
POBA and DCBOther
Standard predilation (POBA) and DCB. 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).
| Study group | Role | What they receive |
|---|---|---|
| Atherectomy | Experimental | Atherectomy and drug-coated balloon (DCB) Receives: Other: Atherectomy |
| Standard care | Active comparator | Standard care with predilation (POBA) and DCB Receives: Other: POBA and DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emerged Adverse Events
Incidence of Treatment-Emerged Adverse Events as assessed by angiography and adverse event assessment
Measured: 6 months Follow Up
Primary patency
determined through doppler ultrasound
Measured: 6 months Follow Up
Secondary outcomes (8)
Bail-out stent rate
success of atherectomy in the SFA including the bail-out stenting rates
Measured: 6 months Follow Up
FMD local
Local endothelial function and vasomotion testing as determinded by FMD of the femoral artery
Measured: 6 months Follow Up
Vessel stiffness
Vascular stiffness determined through pulse wave velocity (PWV)
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
Systemic endothelial function
Change of endothelial function, assessed by the change in the vasodilation after reactive hyperaemia of the brachial artery (flow-mediated dilation = FMD)
Measured: 6 months Follow Up
Change in Plaque burden
Change in plaque burden is measured by plaque volume change using intravascular ultrasound (IVUS)
Measured: during baseline visit
Change in plaque characteristic
Change in plaque characteristic is quantified using virtual histology using intravascular ultrasound (IVUS)
Measured: during baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 Jan 2019
- Primary completion28 Jul 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Straub Medical AG
- Responsible party
- Principal investigator, Fadi Al-Rashid, University Hospital, Essen
- Investigators
- Christos Rammos, Principal investigator, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092972
- Sponsor's protocol ID
- SAVioR_CR
- Acronym
- SAVioR
- Status last verified
- Jan 2021
- First submitted
- 17 Apr 2019
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rammos C, Manzke A, Lortz J, Messiha D, Petrikhovich O, Janosi RA, Steinmetz M, Rassaf T. Mechanical atherothrombectomy improves endothelial function through plaque burden reduction in PAD. Vasa. 2022 Nov;51(6):377-385. doi: 10.1024/0301-1526/a001034. Epub 2022 Oct 4.
PubMed 36193630
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Interventional Treatment Through Atherectomy to Improve Vascular Functions and Patency in Symptomatic Peripheral Artery Disease - Pilot Study
- ClinicalTrials.gov ID
- NCT04092972
- Acronym / sponsor ID
- SAVioR / SAVioR_CR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Straub Medical AG
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Jul 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 17 Sep 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.
Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atherectomy | Experimental | Other: AtherectomyAtherectomy and drug-coated balloon (DCB) |
| Standard care | Active comparator | Other: POBA and DCBStandard care with predilation (POBA) and DCB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Peripheral artery disease, lesions in the SFA and popliteal artery.
- Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, or 4
- Planed peripheral intervention TASC A-D
- Subject must be between 18 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| AtherectomyStraub Rotarex S atherectomy and drug-coated balloon DCB. 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 | Atherectomy |
| POBA and DCBStandard predilation (POBA) and DCB. 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 | Standard care |
Primary outcome
Treatment-Emerged Adverse Events
Time frame: 6 months Follow Up
Incidence of Treatment-Emerged Adverse Events as assessed by angiography and adverse event assessment
Primary patency
Time frame: 6 months Follow Up
determined through doppler ultrasound
8 secondary outcomes
Bail-out stent rate
Time frame: 6 months Follow Up
FMD local
Time frame: 6 months Follow Up
Vessel stiffness
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
Systemic endothelial function
Time frame: 6 months Follow Up
Change in Plaque burden
Time frame: during baseline visit
Change in plaque characteristic
Time frame: during baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 36193630Rammos C, Manzke A, Lortz J, Messiha D, Petrikhovich O, Janosi RA, Steinmetz M, Rassaf T. Mechanical atherothrombectomy improves endothelial function through plaque burden reduction in PAD. Vasa. 2022 Nov;51(6):377-385. doi: 10.1024/0301-1526/a001034. Epub 2022 Oct 4.
- 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.
Christos Rammos principal investigator
Universität Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atherectomy and POBA and DCB 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 9 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 25 Jan 2021. 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 (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?
Treatment-Emerged Adverse Events (time frame: 6 months Follow Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092972, which also lists 1 linked publication.
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 25 Jan 2021.