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 Withdrawn at 1 site in United States.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
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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.
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.
230 studies on the registry are indexed under Arterial Occlusive Diseases; 27 are open to participants now.
Browse Arterial Occlusive Diseases studies →4 of the 66 studies in Arterial Occlusive Diseases with a site in United States are open now. Recruiting first, the newest first:
Teleflex · Sites in United States, France, Latvia and 1 more country
Ages 18–80
Fundación EPIC · Sites in United States, Belgium, Spain and 1 more country
Ages 18–85
Brigham and Women's Hospital · Sites in United States
Ages 21–80
VA Office of Research and Development · Sites in United States
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 →
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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66 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 11 · Phase 3 9 · Phase 4 4
First in 1996; this study’s year is marked. 3 started in 2014.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 100 across the 51 interventional studies, 170 across the 15 observational. Of the 54 that completed or were terminated, 22 (41%) have results posted.
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30 of 66 have an industry lead sponsor. The 10 most frequent:
Antonios Likourezos is the lead sponsor of 42 studies on the registry; 4 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.
Antonios Likourezos has 1 study filed under Arterial Occlusive Diseases — fewer than ten, so there is no comparison to draw.
2 of the studies in Arterial Occlusive Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06003855VA Office of Research and DevelopmentOxygen-guided Supervised Exercise Therapy | 2026-12-30 |
| NCT06095050Brigham and Women's HospitalEmbolization Treatment of Chronic Refractory Shoulder Tendinopathy | 2027-01-16 |
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Among the 66 studies in Arterial Occlusive Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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
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Exclusion Criteria:
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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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Dec 2014 to primary completion in Oct 2015, 10 months.
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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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Antonios Likourezos