Cerebral VasospasmPhase 4iVASTNCT01996436
The Intra-arterial Vasospasm Trial
A Phase 4 study testing Nicardipine, Verapamil and Nicardipine + Verapamil + Nitroglycerin in people with Cerebral Vasospasm, run by Peng Roc Chen, MD at 5 sites in United States.
Trial summary
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Vasospasm
- What is being tested?
- Nicardipine, Verapamil and Nicardipine + Verapamil + Nitroglycerin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Aug 2016to 12 Aug 2024
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, age 18-80 years old, with ruptured aneurysm(s) who experience cerebral vasospasm post operatively within 3-21 days.
- Symptomatic vasospasm (clinical or TCD)
- For centers that perform a routine day 7 angiogram post-aneurysm treatment - 50% or more stenosis seen on diagnostic angiogram for asymptomatic patients.
Who cannot join
- Inability to obtain consent from patient or patients kin
- Pregnant women
- less than 18 years of age of more than 80 years of age
- Hunt Hess Grade 5 SAH
- Intra-arterial drug treatment in all 3 arterial territories
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Geisinger Clinic
Danville, Pennsylvania, 17822
University of Texas Medical School at Houston
Houston, Texas, 77030
Northwell Health
Manhasset, New York, 11030
Yale School of Medicine
New Haven, Connecticut, 06520
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: The Intra-arterial Vasospasm Trial - A Multi-center Randomized Study
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.
We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is more efficacious than single agent treatment cerebral vasospasm therapy.
All procedures done as a part of this study are standard hospital care procedures done to treat cerebral vasospasm and all drugs to be used are FDA approved.
Read the detailed description
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage.
The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.
This study is a prospective multicenter randomized trial. The primary outcome measure is the Post infusion improvement ratio (PIIR) assessed 10 minutes after completion of the intra-arterial infusion. PIIR is a measure of arterial lumen diameter pre and post intra-arterial drug infusion in the presenting vasospasmic blood vessel.
Modified Rankin score (mRS) at 3 months post hospital discharge will be recorded as a secondary outcome to assess clinical outcome.
The interventions in this study are a part of routine standard of care (SOC) procedures for cerebral vasospasm treatment. Following surgical or endovascular intervention for aneurysmal Subarachnoid Hemorrhage (aSAH) if patients develop cerebral vasospasm refractory to maximal medical management, endovascular treatment by intra-arterial drug infusion of single drug agent or cocktail drug agents will be initiated.
Study participants will be randomly assigned to one of the three treatment groups where one single drug agent or cocktail drug agents will be intra-arterially administered. Pre \& post infusion vasospasmic vessel diameters will be compared. The change in diameter will be quantified based on the mean percentage change. Three months post hospital discharge, study participants will be followed up in clinic to evaluate clinical outcome.
The study will require 330 patients in total. The patient population will be hospitalized patients presenting with cerebral vasospasm post aneurysmal subarachnoid hemorrhage.
Subjects will be stratified by randomization into 3 treatment groups.
- Conditions
- Cerebral Vasospasm
- Being tested
- Nicardipine, Verapamil, Nicardipine + Verapamil + Nitroglycerin
- Keywords
- cerebral vasospasm, aneurysmal subarachnoid hemorrhage, intra arterial drug treatment for cerebral vasospasm, nicardipine milrinone nitroglycerin verapamil
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
Also called Cardene
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
VerapamilDrug
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
Nicardipine + Verapamil + NitroglycerinDrug
Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
| Study group | Role | What they receive |
|---|---|---|
| Nicardipine | Active comparator | Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty Receives: Drug: Nicardipine |
| Verapamil | Active comparator | Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty Receives: Drug: Verapamil |
| Nicardipine + Verapamil + Nitroglycerin | Active comparator | Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty Receives: Drug: Nicardipine + Verapamil + Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Infusion Improvement Ratio (PIIR)
Post infusion improvement ratio (PIIR) = ((B - A) / A) *100
A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter
Measured: pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion
Secondary outcomes (1)
Disability or Dependence in Daily Activities as Assessed by the Modified Rankin Score
The modified Rankin Scale (mRS) is used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The Modified Rankin Score (mRS) is scored as follows:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 3 months post discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study start29 Aug 2016
- Primary completion29 Apr 2024
- Study completion12 Aug 2024
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cerebral VasospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peng Roc Chen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Thomas Jefferson University, University of Illinois at Chicago, Wake Forest University Health Sciences, Temple University, Geisinger Clinic, Northwell Health, University of Michigan, Lenox Hill Hospital, Weatherhead Foundation, University of California, Irvine
- Responsible party
- Sponsor-investigator, Peng Roc Chen, MD, The University of Texas Health Science Center, Houston
- Investigators
- Peng R Chen, MD, Principal investigator, University of Texas Medical School at HoustonKetan R Bulsara, MD, MBA, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996436
- Sponsor's protocol ID
- IVT_201310 (HSC-MS-13-0586)
- Acronym
- iVAST
- Status last verified
- Apr 2025
- First submitted
- 12 Nov 2013
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dorsch NW, King MT. A review of cerebral vasospasm in aneurysmal subarachnoid haemorrhage Part I: Incidence and effects. J Clin Neurosci. 1994 Jan;1(1):19-26. doi: 10.1016/0967-5868(94)90005-1.
PubMed 18638721Treggiari MM, Walder B, Suter PM, Romand JA. Systematic review of the prevention of delayed ischemic neurological deficits with hypertension, hypervolemia, and hemodilution therapy following subarachnoid hemorrhage. J Neurosurg. 2003 May;98(5):978-84. doi: 10.3171/jns.2003.98.5.0978.
PubMed 12744357Biller J, Godersky JC, Adams HP Jr. Management of aneurysmal subarachnoid hemorrhage. Stroke. 1988 Oct;19(10):1300-5. doi: 10.1161/01.str.19.10.1300. No abstract available.
PubMed 3176090Kassell NF, Sasaki T, Colohan AR, Nazar G. Cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Stroke. 1985 Jul-Aug;16(4):562-72. doi: 10.1161/01.str.16.4.562.
PubMed 3895589Keuskamp J, Murali R, Chao KH. High-dose intraarterial verapamil in the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2008 Mar;108(3):458-63. doi: 10.3171/JNS/2008/108/3/0458.
PubMed 18312091Linfante I, Delgado-Mederos R, Andreone V, Gounis M, Hendricks L, Wakhloo AK. Angiographic and hemodynamic effect of high concentration of intra-arterial nicardipine in cerebral vasospasm. Neurosurgery. 2008 Dec;63(6):1080-6; discussion 1086-7. doi: 10.1227/01.NEU.0000327698.66596.35.
PubMed 19057319Badjatia N, Topcuoglu MA, Pryor JC, Rabinov JD, Ogilvy CS, Carter BS, Rordorf GA. Preliminary experience with intra-arterial nicardipine as a treatment for cerebral vasospasm. AJNR Am J Neuroradiol. 2004 May;25(5):819-26.
PubMed 15140728Pierot L, Aggour M, Moret J. Vasospasm after aneurysmal subarachnoid hemorrhage: recent advances in endovascular management. Curr Opin Crit Care. 2010 Apr;16(2):110-6. doi: 10.1097/MCC.0b013e3283372ef2.
PubMed 20098322Fraticelli AT, Cholley BP, Losser MR, Saint Maurice JP, Payen D. Milrinone for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2008 Mar;39(3):893-8. doi: 10.1161/STROKEAHA.107.492447. Epub 2008 Jan 31.
PubMed 18239182
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intra-arterial Vasospasm Trial - A Multi-center Randomized Study
- ClinicalTrials.gov ID
- NCT01996436
- Acronym / sponsor ID
- iVAST / IVT_201310 (HSC-MS-13-0586)
- Conditions
- Cerebral Vasospasm
- Keywords
- cerebral vasospasm, aneurysmal subarachnoid hemorrhage, intra arterial drug treatment for cerebral vasospasm, nicardipine milrinone nitroglycerin verapamil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Peng Roc Chen, MDUniversity, hospital or other
- Collaborators
- Yale University, Thomas Jefferson University, University of Illinois at Chicago, Wake Forest University Health Sciences, Temple University, Geisinger Clinic, Northwell Health, University of Michigan, Lenox Hill Hospital, Weatherhead Foundation, University of California, Irvine
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.
We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is more efficacious than single agent treatment cerebral vasospasm therapy.
All procedures done as a part of this study are standard hospital care procedures done to treat cerebral vasospasm and all drugs to be used are FDA approved.
Detailed description
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage.
The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.
This study is a prospective multicenter randomized trial. The primary outcome measure is the Post infusion improvement ratio (PIIR) assessed 10 minutes after completion of the intra-arterial infusion. PIIR is a measure of arterial lumen diameter pre and post intra-arterial drug infusion in the presenting vasospasmic blood vessel.
Modified Rankin score (mRS) at 3 months post hospital discharge will be recorded as a secondary outcome to assess clinical outcome.
The interventions in this study are a part of routine standard of care (SOC) procedures for cerebral vasospasm treatment. Following surgical or endovascular intervention for aneurysmal Subarachnoid Hemorrhage (aSAH) if patients develop cerebral vasospasm refractory to maximal medical management, endovascular treatment by intra-arterial drug infusion of single drug agent or cocktail drug agents will be initiated.
Study participants will be randomly assigned to one of the three treatment groups where one single drug agent or cocktail drug agents will be intra-arterially administered. Pre \& post infusion vasospasmic vessel diameters will be compared. The change in diameter will be quantified based on the mean percentage change. Three months post hospital discharge, study participants will be followed up in clinic to evaluate clinical outcome.
The study will require 330 patients in total. The patient population will be hospitalized patients presenting with cerebral vasospasm post aneurysmal subarachnoid hemorrhage.
Subjects will be stratified by randomization into 3 treatment groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicardipine | Active comparator | Drug: NicardipineGroup 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty |
| Verapamil | Active comparator | Drug: VerapamilGroup 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty |
| Nicardipine + Verapamil + Nitroglycerin | Active comparator | Drug: Nicardipine + Verapamil + NitroglycerinGroup 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient, age 18-80 years old, with ruptured aneurysm(s) who experience cerebral vasospasm post operatively within 3-21 days.
- Symptomatic vasospasm (clinical or TCD)
- For centers that perform a routine day 7 angiogram post-aneurysm treatment - 50% or more stenosis seen on diagnostic angiogram for asymptomatic patients.
Key exclusion criteria (5 listed)
- Inability to obtain consent from patient or patients kin
- Pregnant women
- less than 18 years of age of more than 80 years of age
- Hunt Hess Grade 5 SAH
- Intra-arterial drug treatment in all 3 arterial territories
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicardipineAlso: CardenePharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm | Drug | Nicardipine |
| VerapamilPharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm | Drug | Verapamil |
| Nicardipine + Verapamil + NitroglycerinPharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm | Drug | Nicardipine + Verapamil + Nitroglycerin |
Primary outcome
Post Infusion Improvement Ratio (PIIR)
Time frame: pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion
Post infusion improvement ratio (PIIR) = ((B - A) / A) *100 A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter
1 secondary outcome
Disability or Dependence in Daily Activities as Assessed by the Modified Rankin Score
Time frame: 3 months post discharge from hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18638721Dorsch NW, King MT. A review of cerebral vasospasm in aneurysmal subarachnoid haemorrhage Part I: Incidence and effects. J Clin Neurosci. 1994 Jan;1(1):19-26. doi: 10.1016/0967-5868(94)90005-1.
- Background: PubMed 12744357Treggiari MM, Walder B, Suter PM, Romand JA. Systematic review of the prevention of delayed ischemic neurological deficits with hypertension, hypervolemia, and hemodilution therapy following subarachnoid hemorrhage. J Neurosurg. 2003 May;98(5):978-84. doi: 10.3171/jns.2003.98.5.0978.
- Background: PubMed 3176090Biller J, Godersky JC, Adams HP Jr. Management of aneurysmal subarachnoid hemorrhage. Stroke. 1988 Oct;19(10):1300-5. doi: 10.1161/01.str.19.10.1300. No abstract available.
- Background: PubMed 3895589Kassell NF, Sasaki T, Colohan AR, Nazar G. Cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Stroke. 1985 Jul-Aug;16(4):562-72. doi: 10.1161/01.str.16.4.562.
- Background: PubMed 18312091Keuskamp J, Murali R, Chao KH. High-dose intraarterial verapamil in the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2008 Mar;108(3):458-63. doi: 10.3171/JNS/2008/108/3/0458.
- Background: PubMed 19057319Linfante I, Delgado-Mederos R, Andreone V, Gounis M, Hendricks L, Wakhloo AK. Angiographic and hemodynamic effect of high concentration of intra-arterial nicardipine in cerebral vasospasm. Neurosurgery. 2008 Dec;63(6):1080-6; discussion 1086-7. doi: 10.1227/01.NEU.0000327698.66596.35.
- Background: PubMed 15140728Badjatia N, Topcuoglu MA, Pryor JC, Rabinov JD, Ogilvy CS, Carter BS, Rordorf GA. Preliminary experience with intra-arterial nicardipine as a treatment for cerebral vasospasm. AJNR Am J Neuroradiol. 2004 May;25(5):819-26.
- Background: PubMed 20098322Pierot L, Aggour M, Moret J. Vasospasm after aneurysmal subarachnoid hemorrhage: recent advances in endovascular management. Curr Opin Crit Care. 2010 Apr;16(2):110-6. doi: 10.1097/MCC.0b013e3283372ef2.
- Background: PubMed 18239182Fraticelli AT, Cholley BP, Losser MR, Saint Maurice JP, Payen D. Milrinone for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2008 Mar;39(3):893-8. doi: 10.1161/STROKEAHA.107.492447. Epub 2008 Jan 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng R Chen, MD principal investigator
University of Texas Medical School at Houston
Ketan R Bulsara, MD, MBA principal investigator
UConn Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicardipine, Verapamil and Nicardipine + Verapamil + Nitroglycerin in people with Cerebral Vasospasm, run by Peng Roc Chen, MD at 5 sites 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 11 May 2025). 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?
Post Infusion Improvement Ratio (PIIR) (time frame: pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion). 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 NCT01996436, which also lists 9 linked publications.
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 11 May 2025.