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Percutaneous Coronary Intervention (PCI) for Coronary Artery Disease

Arizona Cardiovascular Research, Phoenix, AZ
Coronary Artery Disease+2 More ConditionsPercutaneous Coronary Intervention (PCI) - Procedure
Eligibility
Any Age
All Sexes

Study Summary

This trial will compare the outcomes of two different strategies for managing concomitant CAD in patients undergoing TAVR: complete revascularization vs. medical therapy alone.

Eligible Conditions
  • Coronary Artery Disease
  • Coronary Artery Stenosis
  • Aortic Stenosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 22 Secondary · Reporting Duration: Median follow-up of 3.5 years

During PCI procedure
Contrast Utilization for Stages PCI Procedure
Bleeding time procedure
Immediately post-TAVR
Transaortic gradient immediately post-TAVR (echocardiographically-derived vs. direct invasive measurement)
Year 5
All-cause Mortality
Angina status
Bleeding
Cardiovascular Death
Cardiovascular Death or New Myocardial Infarction
Composite of CV Death, New MI, IDR or Hospitalization for UA or for HF in patients with PPM and elevated gradients vs those without
Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure
Composite outcome of mean echocardiographic gradient ≥ 20mmHg, severe PPM, ≥ moderate AR, thrombosis, endocarditis, and aortic valve re-intervention
Contrast-associated acute kidney injury
Economic evaluation
Hospitalization for Unstable Angina or Heart Failure
Ischemia-Driven Revascularization
New Myocardial Infarction
Participant-reported outcomes
Patient-reported outcomes
Severe Patient Prosthesis Mismatch (PPM) Reclassification
Stroke
Transaortic Gradient Reclassification
VARC-3 Hemodynamic Valve Deterioration Reclassification
during PCI procedure
total volume of contrast used during PCI procedure

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Medical Therapy Alone
1 of 2
Complete Revascularization
1 of 2

Active Control

Experimental Treatment

4000 Total Participants · 2 Treatment Groups

Primary Treatment: Percutaneous Coronary Intervention (PCI) · No Placebo Group · N/A

Complete Revascularization
Procedure
Experimental Group · 1 Intervention: Percutaneous Coronary Intervention (PCI) · Intervention Types: Procedure
Medical Therapy AloneNoIntervention Group · 1 Intervention: Medical Therapy Alone · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Percutaneous Coronary Intervention (PCI)
2019
Completed Phase 3
~1190

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: median follow-up of 3.5 years

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,354 Previous Clinical Trials
1,560,859 Total Patients Enrolled
9 Trials studying Coronary Artery Disease
12,350 Patients Enrolled for Coronary Artery Disease
David A Wood, MDPrincipal InvestigatorCCI-CIC, University of British Columbia
2 Previous Clinical Trials
726 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there still opportunities for prospective participants to take part in this clinical investigation?

"Affirmative. According to the clinicaltrials.gov portal, this experiment is currently recruiting volunteers. It was first advertised on December 19th of 2020 and most recently updated on March 31st 2022 with a goal to secure 4000 participants from 26 separate locations." - Anonymous Online Contributor

Unverified Answer

To what extent is the recruitment process for this clinical trial progressing?

"Affirmative, according to clinicaltrials.gov's database this research is actively recruiting. This investigation was initially posted on December 19th 2020 and has been recently modified on March 31st 2022. 4000 patients are necessary for the trial at 26 centers across the country." - Anonymous Online Contributor

Unverified Answer

Where are the primary venues of this clinical experiment?

"This clinical trial has recruited participants from a total of 26 sites, such as St. Joseph Mercy Health System in Ypsilanti, University of Minnesota Medical Center in Minneapolis, and Parkview Research Center in Fort Wayne." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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