Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting firstname.lastname@example.org.
1 study is summarised in this briefing.
The study is a case series including 12 patients treated for an intracranial aneurysm using pCONUS2 assisted coil embolism. The study reports that the pCONUS2 was safe and effectively supported coil occlusion.
The evidence for this technology consists of a case series and case reports. The case series is described in this briefing. There are also 3 case reports of individual patients (Varrassi et al. 2018; Perez et al. 2018; Viso et al. 2018) that describe the safety and efficacy of pCONUS2 to assist the coil occlusion of an aneurysm, and 1 case report of a procedure using the pCONUS2 with the hydrophilic polymer coating (Henkes et al. 2019).
The case series summarised in this section is included in a systematic review and meta-analysis (Sorenson et al. 2019) that reviewed 201 intracranial aneurysm cases treated with coil occlusion using either pCONUS or pCONUS2. The study only included 1 pCONUS2 product but because the versions are similar the results are likely to be generalisable.
There is evidence on the safety of pCONUS2 but none on comparative clinical efficacy or systematic benefit. Comparative evidence assessing how pCONUS2 affects the success rate of coil occlusion, retreatment rate, and treatment without dual antiplatelet therapy would be useful.
The device was successfully inserted in all patients. Ten patients had Modified Raymond-Roy Classification (MRRC) grade 1 occlusion, 2 had MRRC grade 2 occlusion. The device successfully prevented coil protrusion in 10 of the 12 patients. Small non-occlusive thrombi were seen in 3 patients. Six patients had post-treatment angiography (mean follow-up time 4.6 months): 4 showed stable occlusion, 1 showed a small stable neck remnant and 1 showed deterioration with recanalisation of the aneurysm.
This small case series is low-quality evidence. Because it is retrospective the likelihood of selection bias is increased. Ten of the 12 patients were women, limiting the generalisability of the results to men. Two of the patients were also treated with an embolisation device. Uncontrolled variables in the study may confound the results. All patients had dual antiplatelet therapy.
pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2 (pToWin2). ClinicalTrials.gov identifier: NCT03273478. Status: ongoing but not recruiting. Indication: intracranial aneurysm. Devices: pCONUS2, Phenox GmbH. Date: expected completion Dec 2021. Location: US.