Final Results of the Complete Registry: A Global Prospective Real: World Registry Evaluating the Performance of the Penumbra System for Large Vessel Occlusion Thrombectomy

Background: The COMPLETE registry was done to evaluate the performance of a mechanical thrombectomy system in patients with large-vessel occlusion, acute ischemic stroke (LVO-AIS) in a real-world setting.

Materials and Methods: The globally prospective multicenter COMPLETE registry enrolled LVO-AIS patients aged ≥18 years with prestroke modified Rankin's scale (mRS) 0 to 1 who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device (Penumbra, Inc.). The primary safety endpoint was 90-day all-cause mortality. The primary efficacy endpoints were successful postprocedure angiographic revascularization (modified thrombolysis in cerebral infarction [mTICI] ≥ 2b) and 90-day functional outcome (mRS: 0–2). Secondary endpoints included incidence of device- or procedure-related serious adverse events (SAEs), occurrence of embolization in previously uninvolved or new territories (ENT), and occurrence of symptomatic intracranial hemorrhage (sICH) at 24 hours.

Descriptive statistics were calculated for all patients and for three cohorts: anterior circulation LVO with ASPECTS ≥ 6, anterior circulation LVO with ASPECTS < 6, and posterior circulation LVO. A core laboratory evaluated imaging findings and independent medical reviewers reviewed and adjudicated clinical events related to the safety endpoints.

Results: From July 2018 to October 2019, 650 patients were enrolled across 42 centers (29 in the United States and 13 in Europe). Baseline characteristics and endpoints are available in the table.

Conclusion: Mechanical thrombectomy with the Penumbra System in anterior and posterior circulations appears to be safe and effective, resulting in high rates of successful revascularization across all three cohorts.

Publication History

Article published online:
14 December 2021