Radial Artery SpasmPhase 2PASSNCT05861765
The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography
A Phase 2 study testing Papaverine Hydrochloride and normal saline in people with Radial Artery Spasm, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Rationale:Papaverine is effective on radial artery spasm during transradial cerebral angiography. Purpose: This multicenter, randomized, placebo-controlled, double blind, phase 2b trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Spasm
- What is being tested?
- Papaverine Hydrochloride and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2023to 30 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for cerebral angiography will be eligible for screening.
- Participant is willing and is able to give informed consent for participating in the trial.
- Male or Female, aged 18 years or above.
Who cannot join
- Any patient with negative modified Allen test
- Altered liver function
- atrioventricular heart block III degree
- Suspected or confirmed cerebral hemorrhage patients
- Hemodynamic Instability : systolic pressure < 100 mmHg, heart rate > 100 bpm, tachycardia uncontrollable.
- Patients with cerebral edema and increased intracranial pressure within 24 hours to 2 weeks after stroke
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- Coronary artery bypass grafting(CABG) operation history and whose right radial artery is missing as a "bridge vessel"
- Severe skin musculoskeletal malformation of forearm or failure to complete radial artery puncture and sheath placement for other reasons
- Hypersensitivity or contraindication to papaverine
- Hypersensitivity or contraindication to nitroglycerine
- Glaucomatous patients
- Parkinson's disease patients
- Women who are suspected or known to be pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Yamet Tang, M. D., Ph. D, 86-020-34070569, yameitang@hotmail.com
Yamei Tang, M. D., Ph. D
About this study
Official title: The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography: A Randomized Controlled Trial
Rationale:Papaverine is effective on radial artery spasm during transradial cerebral angiography.
Purpose: This multicenter, randomized, placebo-controlled, double blind, phase 2b trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.
Read the detailed description
Radial artery spasm (RAS) is a common complication during transradial cerebral angiography. RAS can lead to severe pain and remains the most frequent cause of transradial angiography failure. There is currently no consensus on the prevention strategy for RAS.
Papaverine has anti vasospasm, sedative and analgesic effects. However, there is no evidence for the efficacy of papaverine in preventing RAS.
This multicenter, randomized, double blind, placebo-controlled trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.
- Conditions
- Radial Artery Spasm
- Being tested
- Papaverine Hydrochloride, normal saline
- Keywords
- Radial artery spasm, Papaverine, Cerebral angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papaverine HydrochlorideDrug
Slowly inject 10ml of papaverine hydrochloride solution (30mg/10ml) through the successfully implanted radial artery sheath, and continuously drip papaverine hydrochloride solution (60mg/500ml, 4ml/min) through the artery sheath during the operation. The compatible solutions are normal saline(0.9%);
normal salineDrug
After inserting the radial artery sheath, slowly inject 10ml normal saline(0.9%) through the artery sheath, then continuously drip normal saline(0.9%, 500ml, 4ml/min) through the artery sheath during the operation.
| Study group | Role | What they receive |
|---|---|---|
| Papaverine | Experimental | Slowly inject 10ml of papaverine hydrochloride solution (30mg/10ml) through the successfully implanted radial artery sheath, and continuously drip papaverine hydrochloride solution (60mg/500ml, 4ml/min) through the artery sheath during the operation. The compatible solutions are normal saline(0.9%); Receives: Drug: Papaverine Hydrochloride |
| Placebo | Placebo comparator | After inserting the radial artery sheath, slowly inject 10ml normal saline(0.9%) through the artery sheath, and continuously drip normal saline(0.9%, 500ml, 4ml/min) through the artery sheath during the operation. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of RAS
The primary outcome of this trial is to evaluate the incidence of RAS during surgery. The operator assessed RAS on the basis of a questionnaire addressing the following five signs: persistent forearm pain, pain response on catheter manipulation, pain response to introducer withdrawal, difficult catheter manipulation after being "trapped" by the radial artery with considerable resistance on withdrawal of the introducer. RAS was considered to be indicated by the presence of at least 2 of these 5 signs or by the presence of just 1 when the operator considered it necessary to administer other spasmolytic agent.
Measured: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Secondary outcomes (2)
The pain intensity of the right forearm
Evaluate the pain intensity of the right forearm during the surgery based on the Numerical Rate Scale(NRS), which evaluates the worst pain during the surgery from "0" indicating "No Pain" to "10" indicating "Pain as bad as you can imagine".
Measured: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
The incidence of transradial approach failure
Transradial approach failure is defined as needing to change the route to complete the surgery.
Measured: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start24 May 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radial Artery SpasmStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, PhD, Study chair, Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861765
- Sponsor's protocol ID
- 20230421
- Acronym
- PASS
- Status last verified
- Apr 2023
- First submitted
- 3 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan D, Yang J, Liu M, Xu Y, Feng J, Li H, Luo W, He B, Xiao S, Yang X, Tang Y. Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography (PASS): rationale and design. Stroke Vasc Neurol. 2026 Apr 27;11(2):261-266. doi: 10.1136/svn-2024-003659.
PubMed 40930776
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05861765
- Acronym / sponsor ID
- PASS / 20230421
- Conditions
- Radial Artery Spasm
- Keywords
- Radial artery spasm, Papaverine, Cerebral angiography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale:Papaverine is effective on radial artery spasm during transradial cerebral angiography.
Purpose: This multicenter, randomized, placebo-controlled, double blind, phase 2b trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.
Detailed description
Radial artery spasm (RAS) is a common complication during transradial cerebral angiography. RAS can lead to severe pain and remains the most frequent cause of transradial angiography failure. There is currently no consensus on the prevention strategy for RAS.
Papaverine has anti vasospasm, sedative and analgesic effects. However, there is no evidence for the efficacy of papaverine in preventing RAS.
This multicenter, randomized, double blind, placebo-controlled trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papaverine | Experimental | Drug: Papaverine HydrochlorideSlowly inject 10ml of papaverine hydrochloride solution (30mg/10ml) through the successfully implanted radial artery sheath, and continuously drip papaverine hydrochloride solution (60mg/500ml, 4ml/min) through the artery sheath during the operation. The compatible solutions are normal saline(0.9%); |
| Placebo | Placebo comparator | Drug: normal salineAfter inserting the radial artery sheath, slowly inject 10ml normal saline(0.9%) through the artery sheath, and continuously drip normal saline(0.9%, 500ml, 4ml/min) through the artery sheath during the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients scheduled for cerebral angiography will be eligible for screening.
- Participant is willing and is able to give informed consent for participating in the trial.
- Male or Female, aged 18 years or above.
Key exclusion criteria (13 listed)
- Any patient with negative modified Allen test
- Altered liver function
- atrioventricular heart block III degree
- Suspected or confirmed cerebral hemorrhage patients
- Hemodynamic Instability : systolic pressure < 100 mmHg, heart rate > 100 bpm, tachycardia uncontrollable.
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 |
|---|---|---|
| Papaverine HydrochlorideSlowly inject 10ml of papaverine hydrochloride solution (30mg/10ml) through the successfully implanted radial artery sheath, and continuously drip papaverine hydrochloride solution (60mg/500ml, 4ml/min) through the artery sheath during the operation. The compatible solutions are normal saline(0.9%); | Drug | Papaverine |
| normal salineAfter inserting the radial artery sheath, slowly inject 10ml normal saline(0.9%) through the artery sheath, then continuously drip normal saline(0.9%, 500ml, 4ml/min) through the artery sheath during the operation. | Drug | Placebo |
Primary outcome
The incidence of RAS
Time frame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
The primary outcome of this trial is to evaluate the incidence of RAS during surgery. The operator assessed RAS on the basis of a questionnaire addressing the following five signs: persistent forearm pain, pain response on catheter manipulation, pain response to introducer withdrawal, difficult catheter manipulation after being "trapped" by the radial artery with considerable resistance on withdrawal of the introducer. RAS was considered to be indicated by the presence of at least 2 of these 5 signs or by the presence of just 1 when the operator considered it necessary to administer other spasmolytic agent.
2 secondary outcomes
The pain intensity of the right forearm
Time frame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
The incidence of transradial approach failure
Time frame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Derived from this study: PubMed 40930776Pan D, Yang J, Liu M, Xu Y, Feng J, Li H, Luo W, He B, Xiao S, Yang X, Tang Y. Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography (PASS): rationale and design. Stroke Vasc Neurol. 2026 Apr 27;11(2):261-266. doi: 10.1136/svn-2024-003659.
- 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.
Yamei Tang, PhD study chair
Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Papaverine Hydrochloride and normal saline in people with Radial Artery Spasm, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 13 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamei Tang, PhD (+86-020-34070569, tangym@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of RAS (time frame: Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.). 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 NCT05861765, 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 12 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.