NCT03368144: BELTHROM

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

Completed NA Last updated 16 October 2024

What this trial tests

NA trial testing ClearLumen II Peripheral Thrombectomy System in Peripheral Arterial Disease in 25 participants. Completed in 7 October 2021.

Timeline

21 November 2017

Primary endpoint
5 August 2019

7 October 2021

Quick facts

Lead sponsor	ID3 Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	21 November 2017
Primary completion	5 August 2019
Estimated completion	7 October 2021
Sites	3 locations across Belgium

Drugs / interventions tested

• ClearLumen II Peripheral Thrombectomy System

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

ID3 Medical

Who can join

18 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.