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Orbital Atherectomy (OA) for Coronary Artery Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Coronary Artery Disease+2 MoreOrbital Atherectomy - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will compare two methods for treating severely calcified heart arteries before implantation of a drug-eluting stent.

Eligible Conditions
  • Coronary Artery Disease
  • NSTEMI (Non ST Segment Elevation Myocardial Infarction)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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SSKI (Potassium Iodide)
1
Medium ACT Target
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FDY-5301

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 1-Year

1-Year
Target Vessel Failure (TVF)
Procedure
Acute Minimum Stent Area (MSA)
Procedural Success
Strategy Success

Trial Safety

Safety Progress

1 of 3

Similar Trials

3
SSKI (Potassium Iodide)
2
Medium ACT Target
3
FDY-5301

Trial Design

2 Treatment Groups

Orbital Atherectomy (OA)
1 of 2
Conventional Balloon Angioplasty
1 of 2

Active Control

2000 Total Participants · 2 Treatment Groups

Primary Treatment: Orbital Atherectomy (OA) · No Placebo Group · N/A

Orbital Atherectomy (OA)
Device
ActiveComparator Group · 1 Intervention: Orbital Atherectomy · Intervention Types: Device
Conventional Balloon Angioplasty
Device
ActiveComparator Group · 1 Intervention: Balloon · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1-year

Who is running the clinical trial?

Cardiovascular Research Foundation, New YorkOTHER
18 Previous Clinical Trials
19,374 Total Patients Enrolled
9 Trials studying Coronary Artery Disease
12,672 Patients Enrolled for Coronary Artery Disease
Cardiovascular Systems IncLead Sponsor
16 Previous Clinical Trials
5,302 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
853 Patients Enrolled for Coronary Artery Disease
Ajay Kirtane, MD, SMPrincipal InvestigatorColumbia University Medical Center / New York-Presbyterian Hospital
2 Previous Clinical Trials
525 Total Patients Enrolled
Philippe Généreux, MDPrincipal InvestigatorMorristown Medical Center
4 Previous Clinical Trials
2,186 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
265 Patients Enrolled for Coronary Artery Disease

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have signed the IRB or EC approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures.
References

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