The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography

NCT05861765 | Unknown Phase 2

• 1 other identifier: 20230421
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radial Artery Spasm

Keywords

Radial artery spasm; Papaverine; Cerebral angiography

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.

• The incidence of transradial approach failure

  Intraprocedural: From procedure start to application of radial band. Approximate time 30 to 90 minutes.

Other Outcomes (3)

• The risk of death, non fatal myocardial infarction, and stroke

  Within 1 week after surgery

• Severe systemic hypotension

  Within 24 hours after surgery or during surgery

• Complications at the puncture site

  Within 24 hours after surgery

Study Arms (2)

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%);

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.

Drug: normal saline

Interventions

Papaverine Hydrochloride DRUG

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%);

Papaverine

normal saline DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• 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. 2025 Sep 10:svn-2024-003659. doi: 10.1136/svn-2024-003659. Online ahead of print.

  PMID: 40930776 DERIVED

MeSH Terms

Interventions

Papaverine; Saline Solution

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yamei Tang, PhD

  Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Yamei Tang, PhD

CONTACT

+86-020-34070569; tangym@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 17, 2023
• Study Start: May 24, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)