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Ischemic StrokePhase 2ALLYNCT05172934

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

A Phase 2 study testing intra-arterial tenecteplase in people with Ischemic Stroke, run by ProMedica Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, single center, non-randomized, pilot study to assess the feasibility of IA TNK following standard of care mechanical thrombectomy (MT) in patients with AIS. Participants will receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard of care MT. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Ischemic Stroke
What is being tested?
intra-arterial tenecteplase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
11 Apr 2022to 1 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age 18-85
  • 2. Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well
  • 3. a. Patients treated less than 6 hours since last known well with ASPECTS >6. b. Patients treated beyond 6 hours since last known well, CT or MRI perfusion scan showing favorable mismatch profile (Target mismatch profile on CT perfusion or MRI (ischemic core volume is <70ml, mismatch ratio is >1.8 and mismatch volume is >15ml)
  • 4. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or 2c with persistent occlusion(s) in terminal branches not amenable to MT.
  • 5. Signed informed consent

Who cannot join

  • 1. Premorbid modified Rankin scale (mRS) score of 4 or greater
  • 2. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT
  • 3. Platelet count <100,000
  • 4. Known bleeding diathesis
  • 5. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  • 6. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR >1.8
Show all 22Show fewer
  • 7. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
  • 8. Pregnant or lactating
  • 9. Previous known allergy to TNK
  • 10. Major surgery in past 30 days
  • 11. Patient is on or requires dialysis
  • 12. History of intracranial hemorrhage or serious head trauma at any time
  • 13. Any condition in the opinion of the enrolling physician that would preclude the patient from participating
  • 14. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
  • 15. Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) that is refractory to treatment
  • 16. History of acute ischemic stroke in the last 60 days
  • 17. Presumed septic embolus; suspicion of bacterial endocarditis
  • 18. Suspicion of aortic dissection
  • 19. Intracranial neoplasm
  • 20. Any mass effect
  • 21. Any terminal medical condition with life expectancy less than 6 months
  • 22. Concurrent enrollment in another trial that could confound the results of this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

Other trials in United States

About this study

Prospective, single center, non-randomized, pilot study to assess the feasibility of IA TNK following standard of care mechanical thrombectomy (MT) in patients with AIS. Participants will receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard of care MT. Patients enrolled into the study will be followed for 3 months after treatment with IA TNK.

Read the detailed description

As current MT technology is not amenable to retrieval of distal occlusions (M3/M4, etc), we hypothesize that IA lytic may play an important role as an adjunctive therapy to open up distal vessels (after the primary LVO has been removed) to achieve complete or near complete reperfusion. In this pilot trial, our goal is to assess the feasibility and safety of IA Tenecteplase (TNK) as an adjunctive therapy following standard of care mechanical thrombectomy (MT) in patients with AIS. A total of 20 patients will be enrolled into the ALLY pilot study.

Conditions
Ischemic Stroke
Being tested
intra-arterial tenecteplase
Keywords
thrombolytic, stroke, distal emboli
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intra-arterial tenecteplaseDrug

    intra-arterial drug administered after mechanical thrombectomy

Study groups in NCT05172934
Study groupRoleWhat they receive
Intra-arterial TenecteplaseExperimentalParticipants will receive intra-arterial Tenecteplase after achieving mTICI 2b or 2c reperfusion with standard of care MT.
Receives: Drug: intra-arterial tenecteplase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Any Intracranial Hemorrhage and Neurologic Worsening

    Number of participants with any incidence of intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the European Cooperative Acute Stroke Study II (ECASS-II) criteria, within 24 hours (+/- 8 hours) of treatment with IA TNK. This measure was assessed by imaging (NCCT/MRI) done within this time frame for all the enrolled study participants. This is the primary study-specific baseline measure for the ALLY study.

    Measured: 24 hours (+/- 8 hours) post-treatment with intra-arterial Tenecteplase

Secondary outcomes (5)

  1. Ordinal Modified Rankin Scale Score

    Ordinal modified Rankin Scale Score at 90 days (+/- 30 days). The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6). This assessment was assessed by the study site personnel. The mRS score could have been obtained over the phone via a structured questionnaire if all attempts to perform as in-person assessment had failed.

    Measured: 90 days (+/- 30 days) post-treatment

  2. Final Revascularization Grade

    Final revascularization grade at end of IA treatment using the modified Thrombolysis in Cerebral Infarction (mTICI) scale.

    mTICI of grade 3: complete anterograde perfusion with normal filling of all distal branches.

    mTICI 2c is: Near complete anterograde perfusion to the tissue distal to the baseline occlusion but < 100% (slow flow in a few distal cortical vessels or presence of small distal cortical emboli).

    mTICI 2b is: Anterograde Perfusion to the tissue distal to the baseline occlusion but ≥ 50% of the target ischemic territory.

    The first bolus of intra-arterial TNK was given as soon as possible after mechanical thrombectomy. A dose of 1.5 mL (1 mg/mL) was infused over 1 minute.

    After 5 minutes, reperfusion was assessed. If TICI 3 was not achieved, a second 1.5 mg bolus was given, followed by another 5-minute assessment. If needed, a third 1.5 mg bolus was given in the same way. After the final 5-minute wait, the final mTICI score was recorded.

    Measured: immediate post-treatment

  3. Incidence of Any Asymptomatic Intracranial Hemorrhage

    Number of participants with any incidence of asymptomatic intracranial hemorrhage. This was assessed by the imaging done at 24 hours from the time of treatment. Both NCCT or MRI were acceptable but MRI was preferred.

    Measured: 24-Hour (+/- 8 hours) post-treatment

  4. Number of Boluses

    Number of boluses given to achieve improvement in reperfusion to mTICI 2c and mTICI 3. This was assessed post-procedure immediately. The first bolus of intra-arterial (IA) tenecteplase (TNK) was given as soon as possible after the mechanical thrombectomy (MT) procedure was complete. A dose of 1.5 mL IA TNK (1 mg/mL) will be infused over 1 minute. After the infusion was complete, the investigator waited 5 minutes before checking the reperfusion status. If complete reperfusion (TICI 3) was not achieved, a second 1.5 mg bolus was given over 1 minute, followed again by a 5-minute waiting period before reassessment. If TICI 3 reperfusion was still not achieved, a third 1.5 mg bolus was administered over 1 minute. After this infusion, the investigator waited another 5 minutes and then assessed the reperfusion status. The final modified TICI (mTICI) score will be recorded after the last assessment.

    Measured: Immediate post-procedure

  5. Mortality Rate at Discharge

    This secondary outcome was determined when the participant was discharged, or it was determined on day 6(+/- 1 day).

    Measured: Hospital Discharge (+/-1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start11 Apr 2022
  3. Primary completion12 Sep 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Participants will receive intra-arterial Tenecteplase after achieving mTICI 2b or 2c reperfusion with standard of care mechanical thrombectomy.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05172934
Sponsor's protocol ID
ALLY
Acronym
ALLY
Status last verified
Apr 2026
First submitted
16 Nov 2021
Last updated
6 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zaidi SF, Castonguay AC, Zaidat OO, Jadhav AP, Sheth SA, Haussen DC, Nguyen TN, Burgess RE, Alhajala HS, Gharaibeh K, Salahuddin H, Rao R, Oliver MJ, Jumaa MA. Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial. Stroke. 2025 Feb;56(2):355-361. doi: 10.1161/STROKEAHA.124.048846. Epub 2025 Jan 8.

    PubMed 39772606

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing intra-arterial tenecteplase in people with Ischemic Stroke, run by ProMedica Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Any Intracranial Hemorrhage and Neurologic Worsening (time frame: 24 hours (+/- 8 hours) post-treatment with intra-arterial Tenecteplase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05172934, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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