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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02212626
• Date of registration: 07/08/2014
• Prospective Registration: No
• Primary sponsor: Flanders Medical Research Program
• Public title: Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium In-stent Occlusion ROBINSON
• Date of first enrolment: August 2014
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02212626
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Vascular Disease

Intervention(s)

Device: Rotarex S

Primary Outcome(s)

Absence of procedure related complications [Time Frame: 1 day post-op]

Technical success of the Rotarex device [Time Frame: 1 day post-op]

Secondary Outcome(s)

Serious Adverse Events [Time Frame: up to 6 months]

Target Lesion Revascularization (TLR) [Time Frame: 1 and 6 months]

Clinical success [Time Frame: 1 and 6 months]

Primary patency at 6 month follow-up [Time Frame: 6 months]

Secondary ID(s)

FMRP-130326

Source(s) of Monetary Support

Please refer to primary and secondary sponsors