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Procedure

CTO PCI for Chronic Total Occlusions

N/A
Recruiting
Led By Margaret B Mcentegart, PhD
Research Sponsored by Haukeland University Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned CTO PCI in accordance with the European and American appropriateness criteria
Be older than 18 years old
Must not have
Flush aorto-ostial occlusion of RCA and Left Main (LMS)
Prior radiation skin injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 & 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a planned two-stage procedure for treating Chronic Total Occlusions (CTOs) can make the treatment safer, more successful, and provide a better patient experience. The initial results

Who is the study for?
This trial is for patients who can consent to the study, follow the schedule, and are planned for a high-risk CTO PCI according to European and American criteria. Details on who cannot participate are not provided.
What is being tested?
The trial tests whether a 'planned investment procedure' in treating chronic total occlusions (CTO) of heart arteries improves safety, success rates, and patient experience compared to traditional methods.
What are the potential side effects?
Specific side effects aren't listed but may include typical risks associated with percutaneous coronary interventions such as bleeding, blood vessel damage, heart attack or arrhythmias.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart procedure is approved by European and American standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heart's main arteries are blocked at their origin.
Select...
I have had skin damage from previous radiation treatment.
Select...
I cannot take dual antiplatelet therapy due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 & 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 & 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compositie safety endpoint
Effectiveness
Secondary study objectives
CTO PCI investment procedural success
CTO PCI technical success
Composite Clinical endpoint
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Invest CTO PCIExperimental Treatment1 Intervention
A pre-planned two staged procedure in high-risk CTO PCI

Find a Location

Who is running the clinical trial?

Haukeland University HospitalLead Sponsor
480 Previous Clinical Trials
362,862 Total Patients Enrolled
Golden Jubilee National HospitalOTHER_GOV
47 Previous Clinical Trials
14,030 Total Patients Enrolled
Margaret B Mcentegart, PhDPrincipal InvestigatorGolden Jubilee National Hospital
~21 spots leftby Apr 2025
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