Peripheral Vascular DiseasePhase 4ROBINSONNCT02212626
Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium In-stent Occlusion
A Phase 4 study testing Rotarex S in people with Peripheral Vascular Disease, run by Flanders Medical Research Program at 5 sites in Belgium.
Trial summary
The objective of this study is to evaluate the safety and efficacy of recanalization of acute and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Rotarex S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesBelgium
- Study dates
- Aug 2014to Jan 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient is >18 years old
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a projected life-expectancy of at least 6 months
- Symptomatic acute or subacute stent occlusion in the femoropopliteal artery
- Target vessel diameter ≥ 3 mm and ≤ 8 mm
- Patient is candidate for thrombolytic or anticoagulation medication
- Patient is able and willing to comply with study follow-up requirements
Who cannot join
- No patent artery until the foot
- Inability of crossing lesion with guidewire
- Known active infection at the time of intervention
- Untreated flow-limiting inflow lesions
- Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrolment
- Aneurysm in the target vessel
Show all 39Show fewer
- Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol
- Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
- Septicemia or bacteremia
- Any previously known coagulation disorder, including hypercoagulability
- Contraindication to anticoagulation or antiplatelet therapy
- Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- Currently participating in another clinical research trial
- The patient must be excluded in case any of the following contraindications as listed in the IFU is present:
- Rotarex®S catheters must not be used in case of:
- Patient not suitable for thrombectomy
- Target vessel belonging to the vessels of the cardiopulmonary, coronary or cerebral circulations
- Use inside or via undersized or oversized vessel diameters
- Impossibility to pass the lesion completely with the guidewire
- Subintimal position of the guidewire - even if only in short segments
- Use in stents or stent grafts if the guidewire has become threaded at any point in the wire mesh of stent or stent graft or the lining of the stent graft
- The introducer sheath, the guide catheter, the guidewire or the Rotarex®S catheter sustaining any damage, especially kinking
- Target lesions situated in the fracture areas of broken stents
- Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure
- Persistent vasospasm
- Imaging by Magnetic Resonance Imaging (MRI)
- Use of a defibrillator on the patient
- Use of electrosurgery on the patient
- Veterinary purposes
- Patients with hemodynamic instability or shock
- Patients with severe coagulatory disorders
- Situations where an embolism potentially triggered by the use of the catheter may have a very harmful effect on the patient
- Use inside or via narrow vessel radii or in tortuous vessel courses (radius of curvature < 2cm)
- Target lesion in severely calcified vessel segments
- Target lesion in aneurysmatically altered vessel segments
- Known or suspected infection, especially of the puncture site or the vessel segment being treated
- Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused by surgical procedures or interventional complications
- Impossibility to achieve sufficient anticoagulation and platelet aggregation inhibition
- Patient is pregnant or nursing a child
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
OLV Hospital
Aalst, 9300
Imelda Hospital
Bonheiden, 2820
AZ Sint-Blasius
Dendermonde, 9200
UZA
Edegem, 2650
RZ Heilig Hart Hospital
Tienen, 3300
About this study
The objective of this study is to evaluate the safety and efficacy of recanalization of acute and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical)
Read the detailed description
The treatment of acute and subacute thromboembolic and local thrombotic ischemic lesions of the ilaco-popliteal segments in the lower extremities has undergone considerable changes over recent years. The standard modality of surgical thrombectomy with the Fogarty balloon catheter technique for acute arterial occlusions has been replaced by percutaneous catheter techniques, i.e. percutaneous aspiration thrombectomy (PAT) for thrombus aspiration. Alternatively, catheter-directed pharmacologic thrombolytic therapy with or without additional catheter aspiration is used, particularly if the occlusion is already a few days or weeks old. These techniques obtain the best results in acute occlusions of less than 2 weeks' duration.
Both techniques have limitations such as the application of fibrinolytic substances and technical, impossibility of rapid and complete thrombus extraction. Therefore various mechanical devices have been introduced which involve maceration or fragmentation and removal of thrombus. The two categories of devices for mechanical thrombectomy (MT) are: (1) rotational recirculation devices which work by the vortex principle, such as the Amplatz thrombectomy catheter (ATD, Microvena, White Bear Lake, MN) or the Arrow-Trerotola PTD (Arrow International, Reading, PA); and (2) hydrodynamic (rheolytic) recirculation devices which operate on the principle of the Venturi effect, such as the Hydrolyser (Cordis, Johnson and Johnson, Miami, FL), Oasis (Boston Scientific, Galway, Ireland), and the Angiojet (RTC; Possis Medical, Minneapolis, MN) [5-10]. These devices are not suited for subacute occlusions of more than 7-14 days' duration. Recently, a new rotational mechanical thrombectomy catheter, the Straub Rotarex / Aspirex (Straub Medical, 7323 Wangs, Switzerland) has been introduced. This device combines the two essential effects of mechanical clot fragmentation and removal of the fragmented clot material from the vessel by negative pressure. Two studies using the Rotarex system with 38, resp. 98 patients showed a primary patency rate of 62%, resp. 54% at 6 months and described the Rotarex / Aspirex systems as an efficient and quick technique for revascularization of acute femoropopliteal de novo occlusions. A more recent publication dating from 2011 reports results from using Rotarex® catheters for treatment of in-stent reocclusions of femoropopliteal arteries. In 78 patients, the restenosis rate was calculated as 18.4% after 12 months.
The purpose of this Belgian multi-center study is to follow-up patients after recanalization with the Rotarex®S catheter system (Straub Medical) for acute and subacute femoropopliteal stent occlusions.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Rotarex S
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarex SDevice
| Study group | Role | What they receive |
|---|---|---|
| Rotarex | Experimental | After assessment of the lesion by angiography the occlusion is intraluminally crossed with the wire according to physician's discretion. The device is introduced and the catheter is activated while its tip is still proximal to the occlusion to allow lubrication of the spiral inside the catheter with the aspirated blood. The catheter is advanced into the occlusion with occasional retraction into the already recanalized lumen. Care must be taken to achieve sufficient cooling of the catheter tip and evacuation of the debris to get an appropriate blood flow along the catheter. In order to minimize peripheral embolization of clot the distal end of the occlusion should not be passed too fast before all loose material has been sucked back into the catheter. Several passages of the occlusion may be needed to clean out all wall-adherent thrombotic material. If residual underlying stenosis of >30% persist further endovascular treatment can be performed according to the physician's discretion. Receives: Device: Rotarex S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of the Rotarex device
Defined as removal of all thrombotic material, documented by angiography pre- and post-procedure: residual stenosis of the lesion <30%.
Measured: 1 day post-op
Absence of procedure related complications
Embolization, amputation, perforation or hemorrhage.
Measured: 1 day post-op
Secondary outcomes (4)
Primary patency at 6 month follow-up
Defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the 6-month follow-up.
Measured: 6 months
Target Lesion Revascularization (TLR)
Defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.
Measured: 1 and 6 months
Clinical success
Defined as an improvement of Rutherford classification at 6 month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Measured: 1 and 6 months
Serious Adverse Events
Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212626
- Sponsor's protocol ID
- FMRP-130326
- Acronym
- ROBINSON
- Status last verified
- Jul 2017
- First submitted
- 7 Aug 2014
- Last updated
- 1 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium In-stent Occlusion
- ClinicalTrials.gov ID
- NCT02212626
- Acronym / sponsor ID
- ROBINSON / FMRP-130326
- Conditions
- Peripheral Vascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Study start
- Aug 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Aug 2014 (estimated)
- 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.
The objective of this study is to evaluate the safety and efficacy of recanalization of acute and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical)
Detailed description
The treatment of acute and subacute thromboembolic and local thrombotic ischemic lesions of the ilaco-popliteal segments in the lower extremities has undergone considerable changes over recent years. The standard modality of surgical thrombectomy with the Fogarty balloon catheter technique for acute arterial occlusions has been replaced by percutaneous catheter techniques, i.e. percutaneous aspiration thrombectomy (PAT) for thrombus aspiration. Alternatively, catheter-directed pharmacologic thrombolytic therapy with or without additional catheter aspiration is used, particularly if the occlusion is already a few days or weeks old. These techniques obtain the best results in acute occlusions of less than 2 weeks' duration.
Both techniques have limitations such as the application of fibrinolytic substances and technical, impossibility of rapid and complete thrombus extraction. Therefore various mechanical devices have been introduced which involve maceration or fragmentation and removal of thrombus. The two categories of devices for mechanical thrombectomy (MT) are: (1) rotational recirculation devices which work by the vortex principle, such as the Amplatz thrombectomy catheter (ATD, Microvena, White Bear Lake, MN) or the Arrow-Trerotola PTD (Arrow International, Reading, PA); and (2) hydrodynamic (rheolytic) recirculation devices which operate on the principle of the Venturi effect, such as the Hydrolyser (Cordis, Johnson and Johnson, Miami, FL), Oasis (Boston Scientific, Galway, Ireland), and the Angiojet (RTC; Possis Medical, Minneapolis, MN) [5-10]. These devices are not suited for subacute occlusions of more than 7-14 days' duration. Recently, a new rotational mechanical thrombectomy catheter, the Straub Rotarex / Aspirex (Straub Medical, 7323 Wangs, Switzerland) has been introduced. This device combines the two essential effects of mechanical clot fragmentation and removal of the fragmented clot material from the vessel by negative pressure. Two studies using the Rotarex system with 38, resp. 98 patients showed a primary patency rate of 62%, resp. 54% at 6 months and described the Rotarex / Aspirex systems as an efficient and quick technique for revascularization of acute femoropopliteal de novo occlusions. A more recent publication dating from 2011 reports results from using Rotarex® catheters for treatment of in-stent reocclusions of femoropopliteal arteries. In 78 patients, the restenosis rate was calculated as 18.4% after 12 months.
The purpose of this Belgian multi-center study is to follow-up patients after recanalization with the Rotarex®S catheter system (Straub Medical) for acute and subacute femoropopliteal stent occlusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotarex | Experimental | Device: Rotarex SAfter assessment of the lesion by angiography the occlusion is intraluminally crossed with the wire according to physician's discretion. The device is introduced and the catheter is activated while its tip is still proximal to the occlusion to allow lubrication of the spiral inside the catheter with the aspirated blood. The catheter is advanced into the occlusion with occasional retraction into the already recanalized lumen. Care must be taken to achieve sufficient cooling of the catheter tip and evacuation of the debris to get an appropriate blood flow along the catheter. In order to minimize peripheral embolization of clot the distal end of the occlusion should not be passed too fast before all loose material has been sucked back into the catheter. Several passages of the occlusion may be needed to clean out all wall-adherent thrombotic material. If residual underlying stenosis of >30% persist further endovascular treatment can be performed according to the physician's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient is >18 years old
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a projected life-expectancy of at least 6 months
- Symptomatic acute or subacute stent occlusion in the femoropopliteal artery
Key exclusion criteria (39 listed)
- No patent artery until the foot
- Inability of crossing lesion with guidewire
- Known active infection at the time of intervention
- Untreated flow-limiting inflow lesions
- Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrolment
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 |
|---|---|---|
| Rotarex S | Device | Rotarex |
Primary outcome
Technical success of the Rotarex device
Time frame: 1 day post-op
Defined as removal of all thrombotic material, documented by angiography pre- and post-procedure: residual stenosis of the lesion <30%.
Absence of procedure related complications
Time frame: 1 day post-op
Embolization, amputation, perforation or hemorrhage.
4 secondary outcomes
Primary patency at 6 month follow-up
Time frame: 6 months
Target Lesion Revascularization (TLR)
Time frame: 1 and 6 months
Clinical success
Time frame: 1 and 6 months
Serious Adverse Events
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotarex S in people with Peripheral Vascular Disease, run by Flanders Medical Research Program at 5 sites in Belgium.
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 39 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: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of the Rotarex device (time frame: 1 day post-op). 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?
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 1 Aug 2017.