Status:
COMPLETED
Belgian Trial Evaluating the ClearLumen II Peripheral Thrombectomy System Recanalization of (sub)acute Thrombotic Femoropopliteal Occlusions
Lead Sponsor:
ID3 Medical
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Ische...
Detailed Description
The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and efficacy of the recanalization of acute and subacute thrombotic (up to 6 weeks) femoropopliteal occ...
Eligibility Criteria
Inclusion
- 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
- 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 hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03368144
Start Date
November 21 2017
End Date
October 7 2021
Last Update
October 16 2024
Active Locations (3)
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1
O.L.V. Hospital
Aalst, Belgium, 9300
2
A.Z. Sint-Blasius
Dendermonde, Belgium, 9200
3
Z.O.L.
Genk, Belgium, 3600