Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium In-stent Occlusion (ROBINSON)
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|ClinicalTrials.gov Identifier: NCT02212626|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease||Device: Rotarex S||Phase 4|
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modality of surgical thrombectomy with the Fogarty balloon catheter technique for acute arterial occlusions has been replaced by percutaneous catheter techniques, i.e. percutaneous aspiration thrombectomy (PAT) for thrombus aspiration.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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
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.
Device: Rotarex S
- 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.
- Primary patency at 6 month follow-up [ Time Frame: 6 months ]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.
- Target Lesion Revascularization (TLR) [ Time Frame: 1 and 6 months ]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.
- Clinical success [ Time Frame: 1 and 6 months ]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.
- Serious Adverse Events [ Time Frame: up to 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212626
|Aalst, Belgium, 9300|
|Bonheiden, Belgium, 2820|
|Dendermonde, Belgium, 9200|
|Edegem, Belgium, 2650|
|RZ Heilig Hart Hospital|
|Tienen, Belgium, 3300|