NCT02339545

Brief Summary

The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

January 9, 2015

Results QC Date

April 8, 2019

Last Update Submit

July 14, 2023

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Coronary Flow Reserve (CFR)

    CFR was measured after successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions. It was calculated from coronary blood flow velocity measurements, which were derived from Doppler-velocity wire data recorded in real time. The CFR formula utilized was APVp/APVb, where APVb is the average peak velocity at baseline and APVp is peak hyperemia.

    Intra-procedurally following successful stent placement. Average procedure time 56 minutes.

Secondary Outcomes (1)

  • Major Adverse Cardiac Events (MACE)

    At 24 hours or at time of hospital discharge, whichever occurred first

Study Arms (1)

All Enrolled Subjects

All subjects will receive Coronary Flow Reserve (CFR) measurements post successful orbital atherectomy treatment and stenting.

Device: Coronary Orbital Atherectomy plus Stenting

Interventions

Coronary Orbital Atherectomy plus StentingDEVICE
Also known as: DIAMONDBACK 360® Coronary Orbital Atherectomy System
All Enrolled Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been determined by their physician to require endovascular intervention for treatment of their CAD.

You may not qualify if:

  • Subjects must be at least 18 years of age.
  • Subjects must be scheduled for percutaneous coronary intervention involving stent deployment in de novo coronary lesions.
  • The target vessel must be a de-novo coronary artery with a severely calcified lesion.
  • The target vessel reference diameter must be ≥ 2.0mm and ≤ 4.0 mm.
  • The lesion length must not exceed 40 mm.
  • The target vessel must have a thrombolysis in myocardial infarction (TIMI) flow 3 at baseline.
  • The target lesion must have fluoroscopic, intravascular ultrasound (IVUS) or optical coherence tomograph (OCT) evidence of severe calcium deposit at the lesion site based on the protocol definition.
  • The lesion must be crossable with the ViperWire Advance® coronary guide wire.
  • Successful revascularization using OAS and stent deployment as demonstrated by no evidence of stent dissection and no more than 50% stenosis proximal to the stent.
  • Inability to understand the study or a history of non-compliance with medical advice.
  • Unwilling or unable to sign the informed consent form (ICF).
  • History of any cognitive or mental health status that would interfere with study participation.
  • Currently enrolled in any pre-approval investigational study. Note: This does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints.
  • Female subjects who are pregnant or planning to become pregnant within the study period.
  • Previous myocardial infarction of the target vessel.
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chandler Regional Medical Center and Mercy Gilbert Medical Center

Chandler, Arizona, 85224, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Results Point of Contact

Title
Clinical Trials Manager
Organization
Cardiovascular Systems, Inc.
clinicaltrials_csi@csi360.com
651.259.2500

Study Officials

  • Nabil Dib, MD

    Dignity Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 15, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 18, 2023

Results First Posted

July 5, 2019

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)