NCT02480348

Brief Summary

The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
3 countries

15 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

June 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

December 3, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2019

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

June 19, 2015

Last Update Submit

July 2, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.

    9 months

Study Arms (1)

Polymer-free DES (Drug Eluting Stent)

EXPERIMENTAL
Device: Polymer-free DES (Drug Eluting Stent)

Interventions

Polymer-free DES (Drug Eluting Stent)DEVICE
Polymer-free DES (Drug Eluting Stent)

Eligibility Criteria

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

You may qualify if:

  • Must be an acceptable candidate for percutaneous coronary intervention, stenting, \& emergent coronary artery bypass graft (CABG) surgery
  • Must have evidence of ischemic heart disease
  • Must require treatment of either a) a single target lesion amenable to treatment with a 2.25 mm - 3.50 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25 mm - 3.50 mm mm study stent
  • Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

You may not qualify if:

  • Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  • History of a stroke or transient ischemic attack (TIA) within the prior 6 months
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Concurrent medical condition with a life expectancy of less than 5 years
  • Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
  • Documented left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Eastern Heart Clinic - Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

St. Andrew's Hospital

Adelaide, South Australia, 5000, Australia

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Wesley Hospital / HeartCare Partners

Auchenflower, Australia

Location

Flinders Medical Center

Bedford Park, 5042, Australia

Location

St. Vincent's Hospital

Darlinghurst, 2010, Australia

Location

Royal Brisbane & Women's Hospital

Herston, 4029, Australia

Location

Monash Medical Center

Melbourne, 3168, Australia

Location

Northern Hospital

Melbourne, Australia

Location

Fiona Stanley Hospital

Murdoch, Australia

Location

John Hunter Hospital

New Lambton, Australia

Location

Royal North Shore Hospital

St Leonards, 2065, Australia

Location

Institute Dante Pazzanese of Cardiology

São Paulo, Brazil

Location

National Heart Center Singapore

Singapore, Singapore

Location

Related Publications (1)

  • Worthley SG, Abizaid A, Kirtane AJ, Simon DI, Windecker S, Brar S, Meredith IT, Shetty S, Sinhal A, Almonacid AP, Chamie D, Maehara A, Stone GW; RevElution Investigators. First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study. JACC Cardiovasc Interv. 2017 Jan 23;10(2):147-156. doi: 10.1016/j.jcin.2016.10.020.

    PMID: 28104208DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

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

June 19, 2015

First Posted

June 24, 2015

Study Start

December 3, 2015

Primary Completion

June 16, 2017

Study Completion

October 21, 2019

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

AU(13)SG(1)BR(1)