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Randomized study of Mechanical Thrombectomy vs. best medical treatment for stroke at 24 to 72 hours of Last Known Well

Randomized study of Mechanical Thrombectomy vs. best medical treatment for stroke at 24 to 72 hours of Last Known Well - SKIP-EXTEND

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032230344
Enrollment
260
Registered
2023-09-12
Start date
2023-09-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Stroke

Interventions

To compare the efficacy and safety of endovascular treatment and medical treatment. Endovascular treatment group: General medical treatment is performed in addition to endovascular treatment. Medical
D002548

Sponsors

Kimura Kazumi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 20 years of age or older 2. Patients with acute stroke 24-72 hours after the last healthy check 3. Subjects with a pre-randomization NIHSS score of 6 or higher 4. Subjects with pre-onset modified Rankin Scale score of 2 or less 5. Subjects who can confirm ICA (cervical and intracranial) and M1 obstruction by MRA or CTA 6. Subjects who can undergo endovascular treatment promptly after randomization 7. Pre-allotment detailed DWI-ASPECTS (10-point scale) of 6 or more (ASPECTS are evaluated by detailed DWI-ASPECTS, which deducts points for M1-M6 with a high signal of 1/2 or more) or CT-ASPECTS of 6 or more 8. Subjects who explained this research using an explanation document and obtained written consent

Exclusion criteria

Exclusion criteria: 1. Patients who are unsuitable for endovascular treatment, such as having a history of hypersensitivity to contrast media 2. Patients with serious renal disease (not limited to those on dialysis) 3. Patients who are Lactating, or who are or may be pregnant 4. Patients who are expected to have a life expectancy of 90 days or less 5. Patients with a history of hypersensitivity to contrast media and for whom endovascular treatment is inappropriate

Design outcomes

Primary

MeasureTime frame
Rate of independent living (mRS) 0-2 (ITT) 90 days (+- 10 days) after onset (or final confirmation of good health) (superiority)

Secondary

MeasureTime frame
-Proportion of independent living (mRS) 0-2 (PPS) 90 days (+- 10 days) after onset (or final confirmation of good health) (superiority) -Improvement in mRS 90 days (+- 10 days) after onset (or final confirmation of good health) (ordered logistic regression analysis) (ITT, PPS, AT) (superiority) -Rate of independent living (mRS) 0-1 (ITT) 90 days (+-10 days) after onset (or final confirmation of good health) (superiority) -Rate of independent living (mRS) 0-3 (ITT) 90 days (+-10 days) after onset (or final confirmation of good health) (superiority) -Proportion of recanalization (Modified Mori Grade 3) 48+-36 hours after randomization

Contacts

Public ContactKentaro Suzuki

Nippon Medical School Hospital

kentarow@nms.ac.jp+81-3-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026