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NCT Number: NCT07643922

Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage

Cerebral vasospasm is a common and serious complication after aneurysmal subarachnoid hemorrhage and is an important cause of delayed cerebral ischemia and poor neurological outcomes. Although standardized medical management is widely used, effective treatment options for cerebral vasospasm remain limited.

Endovascular treatment, including intra-arterial drug infusion and mechanical angioplasty, may relieve vasospasm and improve cerebral perfusion after aneurysmal subarachnoid hemorrhage. However, most available evidence comes from retrospective or observational studies, and high-quality randomized evidence remains insufficient. Milrinone is a phosphodiesterase inhibitor with multiple potentially beneficial effects, including vasodilation, positive inotropic activity, anti-inflammatory properties, and endothelial protection. These effects may make milrinone a promising therapeutic agent for relieving cerebral vasospasm, reducing delayed cerebral ischemia, and ultimately improving clinical outcomes after aneurysmal subarachnoid hemorrhage.

This study is a multicenter, prospective, randomized controlled clinical trial designed to evaluate whether early continuous milrinone-based endovascular therapy improves outcomes in patients with cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Eligible participants will be randomly assigned to receive either standardized medical management alone or milrinone-based endovascular therapy plus standardized medical management. In the intervention group, patients will receive intra-arterial milrinone during endovascular treatment, with mechanical angioplasty when clinically indicated, followed by continuous intravenous milrinone infusion for 72 hours after intra-arterial administration.

The study will evaluate whether this continuous treatment strategy reduces poor neurological outcomes at 3 months after randomization. It will also assess the effects of treatment on delayed cerebral ischemia, vasospasm resolution, cognitive function, quality of life and so on. The results of this trial may provide high-quality evidence for early continuous milrinone-based endovascular therapy as a treatment strategy for cerebral vasospasm after aneurysmal subarachnoid hemorrhage.

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Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Vasospasm After Subarachnoid Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases Vasospasm, Intracranial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must meet all of the following criteria:

  • Aged 18 to 80 years.
  • SAH confirmed by cranial CT, with an intracranial aneurysm identified by CTA, MRA, or DSA and determined to be the source of bleeding.
  • Prior treatment of the aneurysm by endovascular intervention or surgical clipping.
  • Evidence suggestive of CVS within 14 days after onset, defined by at least one of the following:
  • Clinical deterioration, including a decrease in GCS score of >2 points and/or a new focal neurological deficit not attributable to another known neurological cause;
  • TCD confirmed vasospasm, defined as mean flow velocity (MFV) >120 cm/s in the middle cerebral artery (MCA) and Lindegaard ratio >3, after excluding other causes of increased flow velocity such as anemia or fever;
  • Vasospasm confirmed by DSA or CTA.

Exclusion criteria

  • Hunt-Hess grade 5 with critical illness and inability to tolerate intervention.
  • Contraindications to milrinone, including milrinone allergy, aortic or pulmonary valve stenosis, obstructive hypertrophic cardiomyopathy, acute coronary syndrome, or malignant arrhythmia.
  • Perioperative procedure-related complications that may interfere with study assessment, such as significant stenosis of the parent artery.
  • Irreversible cerebral infarction involving the entire vascular territory affected by vasospasm.
  • Poor blood pressure control, defined as systolic blood pressure <100 mmHg.
  • Non-aneurysmal SAH, including hemorrhage due to arteriovenous malformation, vasculitis, tumor bleeding, trauma, or other non-spontaneous causes, or cases without an identified bleeding source.
  • Other severe neurological disorders with substantial pre-existing disability (mRS >3), such as progressive cognitive impairment or status epilepticus.
  • Severe systemic disease, including significant cardiac, hepatic, renal, or psychiatric disorders.
  • Pregnant or breastfeeding women, or women planning pregnancy during the study period.
  • Any other condition considered by the investigators to make the patient unsuitable for participation or likely to limit compliance with study procedures.
  • Current participation in another interventional clinical study, inability to complete follow-up assessments, or failure to provide informed consent.

Treatment and study plan

Intra-arterial and Intravenous Milrinone Therapy

Other

Continuous milrinone-based endovascular therapy will be administered in addition to standardized medical management. Cerebral angiography will first be performed, followed by intra-arterial infusion of milrinone 8 mg into the artery supplying the vasospastic territory over approximately 30 minutes. If vasodilation is incomplete, the infusion may be repeated once in the same territory. For diffuse vasospasm, milrinone may be administered in different vascular territories, with a maximum total intra-arterial dose of 24 mg. If severe proximal stenosis persists after intra-arterial treatment, mechanical angioplasty may be performed at the operator's discretion. After intra-arterial treatment, intravenous milrinone will be continued for 72 hours, starting at 0.5 mcg/kg/min and gradually increasing to a maximum of 1.5 mcg/kg/min when clinically needed and well tolerated. If vasospasm recurs, the treatment protocol may be repeated at the investigator's discretion.

Standardized Medical Management

Other

Standardized medical management will be provided after aneurysm treatment for aSAH. It will include oral or enteral nimodipine at a total daily dose of 360 mg, fluid management with 24-hour intake and output monitoring to maintain euvolemia, blood pressure augmentation when clinically indicated to support cerebral perfusion, and other guideline-recommended supportive treatments.

Primary outcomes

  1. Neurological function prognosis

    Time frame: Up to 90 days after randomization

    The primary outcome is poor neurological outcome within 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 3-6.

Secondary outcomes

  1. Delayed cerebral ischemia

    Time frame: Up to 21 days after randomization

    new focal neurological deficit or decreased level of consciousness within 3 weeks after treatment, not attributable to rebleeding, seizure, infection, metabolic disturbance, or other causes, with imaging support for ischemic change (CT/MRI as applicable)

  2. Vasospasm resolution rate

    Time frame: Up to 14 days after randomization/at discharge

    Proportion of participants with vasospasm resolution within 14 days after randomization, defined as a reduction in mean flow velocity of the vasospastic vessel to <120 cm/s on transcranial Doppler, or improvement in vasospasm severity compared with baseline. CTA or DSA may be used when clinically necessary.

  3. Severity of patients' clinical condition

    Time frame: Up to 21 days after randomization。

    assessed at 3 weeks by WFNS grade after treatment, with change from baseline recorded

  4. Cognitive function assessed using the Montreal Cognitive Assessment (MoCA) at baseline and 90 Days

    Time frame: at baseline and 90 days after randomization

    Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function.

  5. Health-related quality of life assessed using the EuroQol 5-Dimension questionnaire (EQ-5D) at 90 Days

    Time frame: 90 days after randomization

    Health-related quality of life will be assessed using the EuroQol 5-Dimension questionnaire (EQ-5D). The EuroQol Visual Analog Scale (EQ VAS) score ranges from 0 to 100, with higher scores indicating better health-related quality of life.

  6. Total Hospitalization Cost

    Time frame: Up to 14 days after randomization/at discharge

    Total hospitalization cost will be calculated as the total cost incurred during the index hospitalization

  7. Length of Total Hospital Stay

    Time frame: Up to 14 days after randomization/at discharge

    Total hospital stay will be measured as the number of days from randomization to hospital discharge

  8. Length of Intensive Care Unit Stay

    Time frame: Up to 14 days after randomization/at discharge

    Intensive care unit stay will be measured as the total number of days spent in the intensive care unit during the index hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Wenqiang Li, MD

CONTACT

[email protected]

13521199810

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Binzhou Medical University
  • Chinese PLA General Hospital
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Wannan Medical College
  • First Affiliated Hospital of Xinjiang Medical University
  • Hebei General Hospital
  • Henan Provincial People's Hospital
  • Hunan University of Medicine General Hospital
  • Ji an central people's Hospital
  • Nanfang Hospital, Southern Medical University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Shaoyang Central Hospital
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Zhengzhou University
  • The second People's Hospital of Guiyang, China
  • Zhongnan Hospital

Registry information

Official study title

Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: The RESCUE-CV Randomized Trial

Acronym: RESCUE-CV

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 12, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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