CompletedNot Applicable

Belgian Trial Evaluating the ClearLumen II Peripheral Thrombectomy System Recanalization of (sub)acute Thrombotic Femoropopliteal Occlusions

Belgium25 participantsStarted 2017-11-21

Plain-language summary

The BELTHROM trial investigates the efficacy and safety of the ClearLumen II Peripheral Thrombectomy System recanalization of acute and subacute thrombotic femoropopliteal occlusions (Acute Limb Ischemia (ALI); Rutherford I, IIa, IIb and III). An expected total of 50 patients will be treated. The lesion is located within the femoropopliteal artery (native, in-stent or bypass graft). During the procedure, the device is introduced, activated and slowly advanced into the occlusion to clean out the wall-adherent thrombotic material. If residual underlying stenosis of \>30% persists additional endovascular treatment can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1 month post-procedure. The primary efficacy endpoint is the technical success of the ClearLumen II Peripheral Thrombectomy System, defined as removal of ≥90% acute clot as documented by angiography. The primary safety endpoint is defined as the absence of device-related complications, which is defined as embolization, perforation or dissection caused by the ClearLumen II Peripheral Thrombectomy System. Secondary endpoints include procedural success, percent clot removed by the ClearLumen II Peripheral Thrombectomy System, clinical success at 1 month follow-up visit, 30-day target lesion revascularization, 30-days serious adverse events and 30-days adverse events.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presence of acute (less than 14 days) or subacute (2-6 weeks) limb ischemia or acute femoropopliteal thrombus during a revascularization procedure (native, in-stent or bypass graft) (acute limb ischemia (ALI) Rutherford I, IIa, IIb, III) * 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 is candidate for thrombolytic, anticoagulation or antiplatelet therapy * Target vessel diameter ≥ 3 mm Exclusion Criteria: * Chronic total occlusion of the target segment * Absence of at least one continuous patent runoff vessel to the foot * Inability to cross the lesion with a guidewire * Known bacteremia at the time of intervention * Untreated flow-limiting inflow lesions * Aneurysm in the target vessel * Visual stent deformations/fractures * Severe medical comorbidities (untreated coronary artery disease/congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc) limiting life expectancy to \< 6 months or other medical condition that in the opinion of the investigator would prelude compliance with the study protocol * Presence of gangrene or osteomyelitis * Any previously known coagulation disorder, including hypercoagulability * Contraindication to anticoagulation or antiplatelet therapy * Patient with known hypersensi…

What they're measuring

Primary efficacy endpoint: Technical success

Timeframe: During index procedure

Primary safety endpoint

Timeframe: During index procedure

Trial details

NCT IDNCT03368144

SponsorID3 Medical

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-05