NCT02212626

Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium In-stent Occlusion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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modality of surgical thrombectomy with the Fogarty balloon catheter technique for acute arterial occlusions has been replaced by percutaneous catheter techniques, i.e. percutaneous aspiration thrombectomy (PAT) for thrombus aspiration.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

Interventions

Type	Name	Description
DEVICE	Rotarex S

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2014-08-08
• Last updated: 2017-08-01

Locations

5 sites across 1 country: Belgium