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WithdrawnNCT02577796Updated Dec 4, 2023

Radial Artery Spasm Leading to Occlusion in Patients Undergoing Coronary Angiogram Via Radial Access

An observational study in Arterial Occlusion and Arterial Spasm, sponsored by Antonios Likourezos. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by Antonios Likourezos · Observational

Why this study was withdrawn
Lack of time and personnel needed to complete study

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 66 studies in Arterial Occlusive Diseases with a site in United States — 4 open to participants now, 6 under way, none of them phase 3. Arterial Occlusive Diseases · United States.

Enrollment
15th of 15
0 · median 170
Started
2014
with 2 others
Observational
15 of 66
none open now
Registered
38th of 66
by date

Among the 66 studies in Arterial Occlusive Diseases with a site in United States, this one is the 15th largest by enrollment of the 15 observational ones that give a count, is one of 3 that started in 2014, is one of 15 observational ones, and was the 38th registered.

Arterial Occlusive Diseases

230 studies on the registry are indexed under Arterial Occlusive Diseases; 27 are open to participants now.

Browse Arterial Occlusive Diseases studies →

Open to participants now

4 of the 66 studies in Arterial Occlusive Diseases with a site in United States are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 20 Arterial Occlusive Diseases studies recruiting now, 13 (65%) set no upper age limit and 2 (10%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Radial artery access is increasingly becoming popular among interventional cardiologists for patients undergoing percutaneous coronary intervention(PCI)/ diagnostic angiography secondary to its low complications rates. However, it is frequently associated with the spasm of the radial artery which can lead to difficulty in catheter manipulation during the procedure and potentially leading to vessel trauma. This vessel trauma can cause activation of coagulation system and formation of clot and subsequently the occlusion of radial artery. In this study the investigators intend to find the association of radial artery spasm with the future development of radial artery occlusion in patients who undergo PCI via radial access.

Read the detailed description

Transradial (TR) approach for PCI has gained widespread popularity secondary to decreased bleeding and reduced vascular access site complications as compared to transfemoral (TF) access. Other advantages of the TR technique include improved patient satisfaction, decreased length of stay and an enhanced economic outlook . Radial artery spasm (RAS) is a well-known obstacle associated with transradial approach and is also the most common cause of procedural failure . The reported incidence of RAS varies from 5% - 30%. Predictors of spasm include younger age, female gender, diabetes, smaller wrist circumference and lower body weight. With the advent of newer techniques such as smaller sheath size, hydrophilic coating of the sheath and use of vasodilator drugs during the procedure the incidence of RAS has reduced significantly but it still continues to be a cumbersome problem. The marked muscle mass in the radial artery wall, which is greater than that of the other arteries, and its high density in alpha-adrenergic receptors explain its propensity to go in to spasm. This spasm produces pain and difficulty in catheter manipulation and thereby increasing the chances of complications such as arterial avulsion. It's hypothesized that there might be vascular endothelial damage during catheter manipulation when patients have RAS which can activate the coagulation cascade and can result in radial artery occlusion.

Radial artery occlusion (RAO) is a frequent complication of radial artery cannulation. In the perioperative period, rates of RAO have been reported to be as high as 30%-40% . Postoperatively, however rate of RAO drop down to as low as 3%-10%. Spontaneous recanalization of the radial artery occurs frequently, and consequently, the prevalence of persistent RAO is much lower post-operatively. Radial artery occlusion can be documented by an abnormal Barbeau's test , visible obstruction on two-dimensional ultrasound or absence of Doppler flow signal distal to the puncture site. Radial artery occlusion is usually clinically quiescent and doesn't require any intervention secondary to dual blood supply of the arm. The presence of RAO, however, makes repeat ipsilateral radial access difficult. Predictors of RAO include low body weight, advanced age, female gender, degree of systemic anticoagulation, the hemostasis process as well as a low radial artery diameter to sheath size ratio. The mechanism for development of RAO are supposed to be thrombus formation following vessel injury, intimal hyperplasia and negative remodeling of the vessel after the stretching that radial artery undergoes during cannulation. Development of RAO has been related to the severity of the lesion suffered by the artery during the procedure thus, radial spasm which supposedly occurs secondary to vessel trauma may be associated with subsequent occlusion of radial artery.

There has been only one study to date by Ruiz-Salmerón et al that looked at the association of RAS with the development of RAO. They found no significant difference in the radial artery occlusion rate in patients who experienced radial artery spasm. The major limitation of that study however was the assessment of radial artery patency by plethysmography and pulse oximetry which could underestimate the true incidence of RAO. However, in this study the investigators intend to use the Doppler ultrasound (the gold standard) to detect the patency of radial artery and will be able estimate the true incidence of RAO in patient who experience RAS during the procedure.

03

Conditions studied

  • Arterial Occlusion
  • Arterial Spasm

Keywords

  • radial artery spasm
  • radial artery occlusion
  • radial access
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with an informed consent undergoing successful and atraumatic transradial cannulation for either diagnostic angiography/percutaneous coronary intervention ( PCI) over 18 years of age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with an undergoing successful and atraumatic transradial cannulation for either diagnostic angiography/percutaneous coronary intervention ( PCI) over 18 years of age

Exclusion criteria

Exclusion Criteria:

  1. Unsuccessful and traumatic radial cannulation
  2. Previous failed attempts at transradial access
  3. Cardiogenic shock
  4. Negative Allen's test
  5. Arterio-Venous Fistula or Graft
  6. Prior upper extremity vascular manipulation resulting in anatomical changes
  7. Upper Extremity vessel stenting
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
30 Days
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Development of radial artery occlusion in patients who had spasm during coronary angiogram

    Assessed by questionnaire filled out separately by the interventionist and the patient

    Time frame: 30 days post procedure

07

Study locations

1 site
  • Maimonides Medical Center
    Brooklyn, New York 11219, United States
08

References and documents

Publications

  • Ruiz-Salmeron RJ, Mora R, Velez-Gimon M, Ortiz J, Fernandez C, Vidal B, Masotti M, Betriu A. [Radial artery spasm in transradial cardiac catheterization. Assessment of factors related to its occurrence, and of its consequences during follow-up]. Rev Esp Cardiol. 2005 May;58(5):504-11. Spanish. PubMed 15899196 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2014 to primary completion in Oct 2015, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2015
First posted
Oct 16, 2015
StartActual
Dec 1, 2014
Primary completionActual
Oct 28, 2015
CompletionActual
Oct 28, 2015
Last update
Dec 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02577796
Lead sponsor
Antonios Likourezos
Responsible party
Antonios Likourezos (Research Administration Director, Maimonides Medical Center) — Sponsor-investigator
First posted
Oct 16, 2015
Start date
Dec 1, 2014
Primary completion
Oct 28, 2015
Completion
Oct 28, 2015
Last update
Dec 4, 2023

Study contacts

Sergey Ayzenberg, MD
principal investigator · Maimonides Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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