NCT03647475

Brief Summary

The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
752

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

4 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

August 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2021

Completed
14 days until next milestone

Results Posted

Study results publicly available

May 6, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

August 17, 2018

Results QC Date

March 5, 2021

Last Update Submit

October 28, 2021

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction

    Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]

    One Month to one year

Secondary Outcomes (12)

  • Number of Participants With Target Lesion Failure

    One Month to One Year

  • Number of Participants With Procedure Success

    Procedure to hospital discharge, an average of 1.3 days

  • All Participants Deaths Including Cardiac Death

    One Month to One Year

  • Number of Patients With Major Cardiac Event

    One Month to One Year

  • Number of Patients With Myocardial Infarction

    One Month to One Year

  • +7 more secondary outcomes

Study Arms (1)

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent

EXPERIMENTAL

Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.

Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT

Interventions

Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPTCOMBINATION_PRODUCT

To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below:
  • Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
  • Age ≥ 75 years old
  • Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
  • Any prior documented intracerebral bleed
  • Any documented stroke in the last 12 months
  • Hospital admission for bleeding during the prior 12 months
  • Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
  • Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI
  • Planned surgery that would require interruption of DAPT (within the next 12 months)
  • Renal failure defined as: Creatinine clearance \<40 ml/min
  • Thrombocytopenia (PLT \<100,000/mm3)
  • Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
  • Expected non-compliance for at least 6 months DAPT for other medical reasons

You may not qualify if:

  • Pregnant and breastfeeding women
  • Subjects requiring a planned PCI procedure after 1 month of index procedure
  • Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
  • Cardiogenic shock
  • Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
  • Subject not expected to comply with long-term single antiplatelet therapy
  • A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
  • PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
  • Participation in another clinical study within 12 months after index procedure
  • Subjects with life expectancy of less than 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Saint Joseph's Hospital Health Center

East Syracuse, New York, 13057, United States

Location

New York- Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

AnMed Health Medical Center

Anderson, South Carolina, 29621, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx ONE US/Japan Investigators. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.

    PMID: 33167705BACKGROUND

  • Kang J, Abdul Ghapar AK, Selvaraj K, Hur SH, Tam CC, Jang Y, Chae IH, Kandzari DE, Kirtane AJ, Latib A, Kedhi E, Lung TH, You SJ, Windecker S, Stone GW, Kim HS. One-Month Dual Antiplatelet Therapy in High Bleeding Risk Asian Patients Undergoing Percutaneous Coronary Intervention - Onyx ONE Clear 2-Year Results. Circ Rep. 2024 Jul 6;6(8):333-340. doi: 10.1253/circrep.CR-24-0037. eCollection 2024 Aug 9.

    PMID: 39132335DERIVED

  • Toth GG, Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Choi JW, Caputo R, Troquay R, Diderholm E, Singh S, Brar SS, Loussararian A, Chetcuti S, Tulli M, Stone GW, Lung TH, Mylotte D. Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging. Cardiovasc Revasc Med. 2024 Jan;58:60-67. doi: 10.1016/j.carrev.2023.07.016. Epub 2023 Jul 24.

    PMID: 37550123DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Cecile Mahoney, Sr. Clinical Research Specialist
Organization
Medtronic Coronary/Renal Denervation (C/RDN)
cecile.c.mahoney@medtronic.com
763-505-1057

Study Officials

  • David Kandzari, MD

    Piedmont Atlanta Hospital, Atlanta, GA

    PRINCIPAL INVESTIGATOR

  • Ajay Kirtane, MD

    New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, multi-center, single arm trial enrolling eligible subjects in the United States and Japan. Subjects will remain in the study with follow-up clinical assessments through 2 years, study exit, or death, whichever comes first.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 27, 2018

Study Start

October 1, 2018

Primary Completion

March 10, 2020

Study Completion

April 22, 2021

Last Updated

November 1, 2021

Results First Posted

May 6, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)