Belgian Trial Evaluating the ClearLumen II Peripheral Thrombectomy System Recanalization of (sub)… (NCT03368144) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.