Angioplasty Clinical Trials

Clinical trials related to Angioplasty Procedure

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

∙ 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.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Department of Neurosurgery, Beijing Tiantan Hospital
NOT_YET_RECRUITING
Beijing
Contact Information
Primary
Wenqiang Li, MD
lwqsurgeon@163.com
13521199810
Time Frame
Start Date: 2026-06-03
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 306
Treatments
Active_comparator: Control Group (Standardized Medical Management Group)
Participants assigned to the control group will receive standardized medical management after aneurysm treatment for aSAH, including oral or enteral nimodipine at a total daily dose of 360 mg, maintenance of euvolemia, blood pressure augmentation when clinically indicated to support cerebral perfusion, and other guideline-recommended supportive treatments.
Experimental: Experimental Group (Continuous Milrinone-Based Endovascular Therapy Plus Standardized Medical Mana )
Participants assigned to this arm will receive standardized medical management as described for the comparator arm plus continuous milrinone-based endovascular therapy. Endovascular angiography will be performed, followed by intra-arterial milrinone 8 mg infused into the artery supplying the vasospastic territory over approximately 30 minutes. The dose may be repeated if clinically needed, with a maximum total intra-arterial dose of 24 mg. Mechanical angioplasty may be considered for persistent severe proximal stenosis. After intra-arterial treatment, intravenous milrinone will be continued for 72 hours at 0.5 to 1.5 μg/kg/min according to clinical need and tolerability. If vasospasm recurs, the treatment protocol may be repeated at the investigator's discretion.
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Nanchang University, First Affiliated Hospital of Wannan Medical College, The second People's Hospital of Guiyang, China, Second Affiliated Hospital, Zhejiang University, School of Medicine, Shaoyang Central Hospital, Binzhou Medical University, The First Affiliated Hospital of Zhengzhou University, Nanfang Hospital, Southern Medical University, Ji an central people's Hospital, Henan Provincial People's Hospital, Hunan University of Medicine General Hospital, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Harbin Medical University, Zhongnan Hospital, Hebei General Hospital, Chinese PLA General Hospital
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov