Last reviewed · How we verify
NCT04157270: LOTUS
LOTUS: Global Acute Stroke Study Utilizing Penumbra System
trial testing Penumbra System in Stroke, Ischemic in 23 participants. Terminated before completion.
10 May 2021
Quick facts
| Lead sponsor | Penumbra Inc. |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 23 |
| Start date | 12 January 2020 |
| Primary completion | 10 May 2021 |
| Estimated completion | 10 May 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Penumbra System
Conditions studied
- Stroke, Ischemic — all drugs for Stroke, Ischemic →
Sponsor
Penumbra Inc. — full company profile →
Who can join
Adults 18 to 85, any sex, with Stroke, Ischemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this study is to demonstrate safety and effectiveness of the Penumbra System in a population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04157270
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Penumbra System
Trials testing the same drug.
- NCT06545864 — Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism · not yet recruiting
- NCT03464565 — COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revasculariz · completed
Other recruiting trials for Stroke, Ischemic
Currently open trials in the same condition.
- NCT07456956 — HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke · NA · recruiting
- NCT06658197 — Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke · Phase 3 · recruiting
- NCT07282041 — Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis · Phase 2, PHASE3 · recruiting
- NCT07135089 — Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban · Phase 3 · recruiting
- NCT07047014 — Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ische · Phase 3 · recruiting
Other Penumbra Inc. trials
Trials by the same sponsor.
- NCT06446024 — Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan · completed
- NCT05684796 — Comparison of Two Pulmonary Embolism Treatments · NA · completed
- NCT05437055 — THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing · NA · completed
- NCT04693767 — Investigation of Clot in Ischemic Stroke and Hematoma Evacuation · completed
- NCT04144959 — A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04157270 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Penumbra Inc.
- Last refreshed: 25 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04157270.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing