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NCT03094715: Tension
Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window
NA trial testing Thrombectomy in Stroke, Acute in 253 participants. Terminated before completion.
31 May 2023
Quick facts
| Lead sponsor | University Hospital Heidelberg |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 253 |
| Start date | 20 June 2018 |
| Primary completion | 31 May 2023 |
| Estimated completion | 15 November 2023 |
| Sites | 42 locations across Denmark, France, Slovakia, Austria, Germany, Norway, Canada, Switzerland |
Drugs / interventions tested
- Thrombectomy
- Best medical care — full drug profile →
Conditions studied
- Stroke, Acute — all drugs for Stroke, Acute →
- Cerebral Stroke — all drugs for Cerebral Stroke →
- Cerebrovascular Stroke — all drugs for Cerebrovascular Stroke →
- Apoplexy; Brain — all drugs for Apoplexy; Brain →
Sponsor
University Hospital Heidelberg
Who can join
18 and older, any sex, with Stroke, Acute or Cerebral Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial.
Bendszus M, Fiehler J, Subtil F, Bonekamp S, et al · · 2023 · cited 360× · PMID 37837989 · DOI 10.1016/s0140-6736(23)02032-9 -
Pathophysiology of Blood-Brain Barrier Permeability Throughout the Different Stages of Ischemic Stroke and Its Implication on Hemorrhagic Transformation and Recovery.
Bernardo-Castro S, Sousa JA, Brás A, Cecília C, et al · · 2020 · cited 258× · PMID 33362697 · DOI 10.3389/fneur.2020.594672 -
Mechanical Thrombectomy in Ischemic Stroke Patients With Alberta Stroke Program Early Computed Tomography Score 0-5.
Kaesmacher J, Chaloulos-Iakovidis P, Panos L, Mordasini P, et al · · 2019 · cited 93× · PMID 30827193 · DOI 10.1161/strokeaha.118.023465 -
Mechanical Thrombectomy for Large Ischemic Stroke: A Systematic Review and Meta-analysis.
Li Q, Abdalkader M, Siegler JE, Yaghi S, et al · · 2023 · cited 89× · PMID 37277200 · DOI 10.1212/wnl.0000000000207536 -
Acute ischaemic stroke: recent advances in reperfusion treatment.
Widimsky P, Snyder K, Sulzenko J, Hopkins LN, et al · · 2023 · cited 82× · PMID 36477996 · DOI 10.1093/eurheartj/ehac684 -
A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window.
Bendszus M, Bonekamp S, Berge E, Boutitie F, et al · · 2019 · cited 69× · PMID 30156479 · DOI 10.1177/1747493018798558 -
Intracranial Hemorrhage After Reperfusion Therapies in Acute Ischemic Stroke Patients.
Maïer B, Desilles JP, Mazighi M. · · 2020 · cited 64× · PMID 33362701 · DOI 10.3389/fneur.2020.599908 -
Cerebral Edema in Patients With Large Hemispheric Infarct Undergoing Reperfusion Treatment: A HERMES Meta-Analysis.
Ng FC, Yassi N, Sharma G, Brown SB, et al · · 2021 · cited 62× · PMID 34384229 · DOI 10.1161/strokeaha.120.033246
Verify or expand the search:
- PubMed search for NCT03094715
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03094715 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Heidelberg
- Last refreshed: 5 December 2023
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/NCT03094715.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing