NCT01638507

Brief Summary

The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

November 25, 2015

Completed
Last Updated

April 3, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

July 9, 2012

Results QC Date

October 23, 2015

Last Update Submit

March 22, 2019

Conditions

Coronary Artery Disease

Keywords

TARGET LESION REVASCULARIZATION (TLR)TARGET VESSEL REVASCULARIZATION (TVR)Coronary Artery DiseaseMYOCARDIAL INFARCTION (MI)PERCUTANEOUS CORONARY INTERVENTION (PCI)STENT THROMBOSISTARGET LESION FAILURE (TLF)

Outcome Measures

Primary Outcomes (1)

  • Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)

    12 months

Secondary Outcomes (9)

  • Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI

    12 months

  • Clinical Endpoint: Death

    12 months

  • Dual Antiplatelet Therapy (DAPT) Compliance

    12 months

  • Clinical Endpoint: TLR

    12 months

  • Clinical Endpoint: TVR

    12 months

  • +4 more secondary outcomes

Study Arms (1)

Resolute Integrity

OTHER

Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)

Device: Resolute Integrity Stent

Interventions

Resolute Integrity StentDEVICE

Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Resolute Integrity

Eligibility Criteria

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

You may qualify if:

  • Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
  • Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
  • Informed consent
  • Patient agrees to comply with specified follow-up evaluations
  • Single target lesion or two target lesions located in separate coronary arteries
  • De novo lesion(s) in native coronary artery(ies)
  • Target lesion(s) ≤ 27 mm in length
  • Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm

You may not qualify if:

  • Within 7 days of index procedure platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; White Blood Cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
  • Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (CK-MB) \> lab upper limit of normal)
  • Previous PCI of target vessel(s) within 9 months prior to the procedure
  • Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
  • History of stroke or Transient Ischemic Attack (TIA) within prior 6 months
  • Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
  • Inability to comply with required trial antiplatelet regimen
  • Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
  • Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
  • Unprotected left main coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Lisa Bousquette, Clinical Research Director
Organization
Medtronic, Coronary Clinical Affairs
lisa.r.bousquette@medtronic.com
(707) 591-2967

Study Officials

  • Ronald Caputo, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

April 3, 2019

Results First Posted

November 25, 2015

Record last verified: 2019-03

Locations

US(1)