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Procedure

Invest CTO PCI for Angina

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 & 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My heart procedure is approved by European and American standards.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 & 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compositie safety endpoint

Effectiveness

Secondary outcome measures

CTO PCI investment procedural success

CTO PCI technical success

Composite Clinical endpoint

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Invest CTO PCIExperimental Treatment1 Intervention

A pre-planned two staged procedure in high-risk CTO PCI

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Haukeland University HospitalLead Sponsor

464 Previous Clinical Trials

341,087 Total Patients Enrolled

Golden Jubilee National HospitalOTHER_GOV

45 Previous Clinical Trials

14,080 Total Patients Enrolled

Margaret B Mcentegart, PhDPrincipal InvestigatorGolden Jubilee National Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enlist participants for this trial?

"Per information from clinicaltrials.gov, this study is actively seeking eligible participants. It was initially listed on December 8th, 2021 and last revised on February 26th, 2024."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Indeed, the details found on clinicaltrials.gov indicate that this research study is actively seeking volunteers. The trial was initially listed on 12/8/2021 and most recently revised on 2/26/2024. In total, it aims to recruit 200 participants across three designated sites."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The objective of this research, to be assessed within a timeframe lasting as long as 12 weeks, is centered on evaluating composite safety endpoints. Secondary measures encompass procedural success in CTO PCI intervention defined by technical completion, a combined clinical endpoint including cardiac mortality, myocardial infarction (MI), cardiovascular hospitalization and target vessel revascularization; additionally the study will assess quality of life using the European Quality of Life-5 Dimensions tool which evaluates mobility, self-care, daily activities, pain levels or discomfort experienced, and feelings of anxiety or depression. Scores range from 0 to 100 where higher scores indicate superior outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Invest-CTO PCI Trial

2021. "Invest-CTO PCI Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04774913.