Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01745692
Other study ID # GN11NE257
Secondary ID TSA 2011/06
Status Terminated
Phase N/A
First received November 30, 2012
Last updated October 23, 2015
Start date December 2012
Est. completion date July 2015

Study information

Verified date October 2015
Source NHS Greater Glasgow and Clyde
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after stroke. However, drug treatment only succeed in restoring blood flow in a minority of people with clots in the larger arteries (10-25% depending on the size of the blood vessel) and these people also have the most severe strokes and highest risk of death or dependence as a result of the stroke. Current best treatment is therefore least effective in the group with the most severe strokes. Devices that can be fed through the blood vessels to either remove or break up the blood clot in the brain vessels can open this type of large artery blockage. However, using these devices is a highly skilled procedure and it takes some time both to set up the necessary facilities (including anaesthetic, nurses and medical support) and to reach the blockage. The extra time that is required to use these devices may mean that brain tissue is already irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be harmed by opening the artery. There are no completed clinical trials comparing the outcome in people treated with standard stroke treatment and those treated with devices. PISTE is a randomised, controlled trial to test whether additional mechanical thrombectomy device treatment improves functional outcome in patients with large artery occlusion who are given IV thrombolytic drug treatment as standard care.


Recruitment information / eligibility

Status Terminated
Enrollment 65
Est. completion date July 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of supratentorial acute ischaemic stroke

- Male or nonpregnant female =18 years of age

- Clinically significant neurological deficit and NIHSS score =6.

- Eligible for IV rtPA according to standard guidelines and able to be commenced on IV treatment <4.5h after symptom onset.

- Enrolment, randomisation and procedure commencement (groin puncture) possible within 90 minutes of the start of IV rtPA treatment (groin puncture maximum 5.5h after stroke onset).

- Occlusion of the main middle cerebral artery (MCA) trunk, MCA bifurcation or intracranial internal carotid artery(carotidT, M1 or single proximal M2 branch) demonstrated on CTA, MRA, or DSA.

- Interventional device delivery (guide catheter placed beyond aortic arch and angio obtained) can be achieved within 6 hours of onset of the stroke.

- Consent of patient or representative.

- Independent prior to the stroke (estimated mRS 02)

- Expected to be able to be followed up at 3 months

Exclusion Criteria:

- CT evidence of intracranial haemorrhage, or evidence of extensive established hypodensity on CT.

- Clinical history suggestive of subarachnoid haemorrhage even if CT normal.

- Known vascular access contraindications e.g. femoral bypass surgery, tight ipsilateral carotid stenosis, unsuitable proximal vascular anatomy likely to render endovascular catheterisation difficult or impossible.

- Extracranial ICA occlusion or basilar artery occlusion

- Alternative intracranial pathology potentially responsible for the new symptoms

- Medical comorbidities which would preclude safe cerebral vessel catheterisation or which are expected to limit life expectancy to <3 months (eg severe cardiac, renal or hepatic failure, significant coagulopathy, metastatic malignancy)

- Known allergy to radiological contrast

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Mechanical thrombectomy

Drug:
Intravenous rtPA
All patients receive IV alteplase

Locations

Country Name City State
United Kingdom NHS Greater Glasgow and Clyde Glasgow

Sponsors (4)

Lead Sponsor Collaborator
NHS Greater Glasgow and Clyde Newcastle University, University of Edinburgh, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary modified Rankin Scale The proportion with favourable functional outcome defined as mRS 0-2 at 90 (+/-7) days based on the modified Rankin scale structured interview Day 90 +/-7 No
Secondary modified Rankin Scale Full neurological recovery (mRS 0-1 versus 2-6) Day 90+/-7 No
Secondary Mortality Day 90 +/-7 Yes
Secondary modified Rankin Scale Change in distribution of mRS scores adjusted for baseline variables Day 90 +/-7 No
Secondary NIH Stroke Scale (NIHSS) Early major neurological improvement of 8 or more points, or return to NIHSS total score of 0 or 1, at 72 hours (or discharge if earlier) 72 hours No
Secondary Angiographic patency Angiographic patency at 22-36 hours (Core lab assessed), using CTA or MRA 22-36 hours No
Secondary Immediate recanalisation rate Immediate (i.e. end of procedure) recanalisation rates in subjects undergoing interventional procedures (core lab assessed). End of procedure No
Secondary Home Time Days spent at home between stroke and day 90 Day 90 +/-7 No
Secondary Symptomatic intracranial haemorrhage Symptomatic intracranial haemorrhage rates defined as local or remote parenchymal haemorrhage type 2 (PH2 or PHr2 ICH by ECASS 2 definition) on the 22-36 h post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 h, or leading to death (SITS-MOST definition) 22-26h Yes
Secondary Intracranial haemorrhage Any intracranial haemorrhage on 22-36h CT or MRI 22-36 hours Yes
Secondary Significant extracranial bleeding Extracranial bleeding, groin haematoma requiring evacuation / surgery or transfusion Up to day 90 Yes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03463551 - Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic Phase 2
Completed NCT02164357 - Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset N/A
Recruiting NCT01207336 - Combined tDCS+PNS After Acute Stroke Phase 2/Phase 3
Completed NCT03328403 - Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion N/A
Recruiting NCT06379464 - Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study
Completed NCT03971526 - Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke
Recruiting NCT03639922 - Imatinib in Acute Ischaemic Stroke Phase 3
Completed NCT03865225 - Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke N/A
Completed NCT03541668 - Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST) Phase 3
Completed NCT03354429 - THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death Phase 3
Completed NCT01994720 - [SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES] Phase 3
Completed NCT03578822 - Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial Phase 3