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

NCT03368144 | Completed

• 1 other identifier: BELTHROM-20170628
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint: Technical success

  Removal of ≥90% acute clot as documented by angiography

  During index procedure

• Primary safety endpoint

  Absence of device-related complications

  During index procedure

Secondary Outcomes (6)

• Procedural success

  During index procedure

• Target Lesion Revascularization (TLR)

  30 days post-procedure

• Clinical success

  30 days post-procedure

• Serious adverse events (SAEs)

  30 days post-procedure

• Adverse events (AEs)

  30 days post-procedure

Study Arms (1)

ClearLumen II Peripheral Thrombectomy System

EXPERIMENTAL

Patients treated with the ClearLumen II Peripheral Thrombectomy System

Device: ClearLumen II Peripheral Thrombectomy System

Interventions

ClearLumen II Peripheral Thrombectomy System DEVICE

Patients will be treated with the ClearLumen Peripheral Stent Graft System

ClearLumen II Peripheral Thrombectomy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (3)

O.L.V. Hospital

Aalst, 9300, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

Location

Z.O.L.

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Koen Deloose, MD

  ID3 Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: November 21, 2017
• Primary Completion: August 5, 2019
• Study Completion: October 7, 2021
• Last Updated: October 16, 2024

Record last verified: 2021-09

Locations

BE (3)