Peripheral Arterial DiseaseBELTHROMNCT03368144
Belgian Trial Evaluating the ClearLumen II Peripheral Thrombectomy System Recanalization of (sub)acute Thrombotic Femoropopliteal Occlusions
A study testing ClearLumen II Peripheral Thrombectomy System in people with Peripheral Arterial Disease, run by ID3 Medical at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- ClearLumen II Peripheral Thrombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesBelgium
- Study dates
- 21 Nov 2017to 7 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
O.L.V. Hospital
Aalst, 9300
A.Z. Sint-Blasius
Dendermonde, 9200
Z.O.L.
Genk, 3600
About this study
Official title: Belgian Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Evaluation of the Safety and Efficacy of the ClearLumen II Peripheral Thrombectomy System Recanalization of Acute and Subacute Thrombotic Femoropopliteal Occlusions
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.
Read the 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 occlusions with the ClearLumen II Peripheral Thrombectomy System.
Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).
During the procedure, the occlusion needs first to be recanalized by conventional guidewire technique, since the ClearLumen II Peripheral Thrombectomy System is an over-the-wire system (0.035"). After assessment of the lesion by angiography via a common femoral artery approach (contralateral/ipsilateral) the occlusion is intraluminally crossed with the wire according to physician's discretion. Afterwards, the device is introduced and the catheter is activated. Then the catheter is slowly advances into the occlusion. Several passages of the occlusion may needed to clean out all wall-adherent thrombotic material. If residual underlying stenosis of >30% persists additional endovascular treatment can be performed according to the physician's discretion.
The regular follow-up is necessary to monitor the condition of the patient and the result of the procedure. Patients will be invited for a follow-up visit 1 month after the index procedure. The following data will be collected during this follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.
- Conditions
- Peripheral Arterial Disease
- Being tested
- ClearLumen II Peripheral Thrombectomy System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearLumen II Peripheral Thrombectomy SystemDevice
Patients will be treated with the ClearLumen Peripheral Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| ClearLumen II Peripheral Thrombectomy System | Experimental | Patients treated with the ClearLumen II Peripheral Thrombectomy System Receives: Device: ClearLumen II Peripheral Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint: Technical success
Removal of ≥90% acute clot as documented by angiography
Measured: During index procedure
Primary safety endpoint
Absence of device-related complications
Measured: During index procedure
Secondary outcomes (6)
Procedural success
Re-establishment of flow in the target segment with residual stenosis ≤30% using any adjunctive technique as deemed necessary by the investigator
Measured: During index procedure
Target Lesion Revascularization (TLR)
Repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge
Measured: 30 days post-procedure
Clinical success
Improvement of Rutherford classification of one or more classes as compared to the pre-procedure Rutherford classification
Measured: 30 days post-procedure
Serious adverse events (SAEs)
Death, stroke, myocard infarction, unplanned major amputation or any clinical life threatening event
Measured: 30 days post-procedure
Adverse events (AEs)
Any clinical event requiring escalation of therapy or prolonging of the hospitalization as judged by the investigator
Measured: 30 days post-procedure
2nd efficacy endpoint
Percent clot removed by the ClearLumen II Peripheral Thrombectomy System
Measured: During index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start21 Nov 2017
- Primary completion5 Aug 2019
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ID3 Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Study director, ID3 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368144
- Sponsor's protocol ID
- BELTHROM-20170628
- Acronym
- BELTHROM
- Status last verified
- Sep 2021
- First submitted
- 5 Dec 2017
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Evaluation of the Safety and Efficacy of the ClearLumen II Peripheral Thrombectomy System Recanalization of Acute and Subacute Thrombotic Femoropopliteal Occlusions
- ClinicalTrials.gov ID
- NCT03368144
- Acronym / sponsor ID
- BELTHROM / BELTHROM-20170628
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ID3 MedicalUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 occlusions with the ClearLumen II Peripheral Thrombectomy System.
Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).
During the procedure, the occlusion needs first to be recanalized by conventional guidewire technique, since the ClearLumen II Peripheral Thrombectomy System is an over-the-wire system (0.035"). After assessment of the lesion by angiography via a common femoral artery approach (contralateral/ipsilateral) the occlusion is intraluminally crossed with the wire according to physician's discretion. Afterwards, the device is introduced and the catheter is activated. Then the catheter is slowly advances into the occlusion. Several passages of the occlusion may needed to clean out all wall-adherent thrombotic material. If residual underlying stenosis of >30% persists additional endovascular treatment can be performed according to the physician's discretion.
The regular follow-up is necessary to monitor the condition of the patient and the result of the procedure. Patients will be invited for a follow-up visit 1 month after the index procedure. The following data will be collected during this follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ClearLumen II Peripheral Thrombectomy System | Experimental | Device: ClearLumen II Peripheral Thrombectomy SystemPatients treated with the ClearLumen II Peripheral Thrombectomy System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearLumen II Peripheral Thrombectomy SystemPatients will be treated with the ClearLumen Peripheral Stent Graft System | Device | ClearLumen II Peripheral Thrombectomy System |
Primary outcome
Primary efficacy endpoint: Technical success
Time frame: During index procedure
Removal of ≥90% acute clot as documented by angiography
Primary safety endpoint
Time frame: During index procedure
Absence of device-related complications
6 secondary outcomes
Procedural success
Time frame: During index procedure
Target Lesion Revascularization (TLR)
Time frame: 30 days post-procedure
Clinical success
Time frame: 30 days post-procedure
Serious adverse events (SAEs)
Time frame: 30 days post-procedure
Adverse events (AEs)
Time frame: 30 days post-procedure
2nd efficacy endpoint
Time frame: During index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Deloose, MD study director
ID3 Medical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearLumen II Peripheral Thrombectomy System in people with Peripheral Arterial Disease, run by ID3 Medical at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint: Technical success (time frame: During index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.