NCT01899235

Brief Summary

A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.

Trial Health

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Trial Health Score

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

Timeline
Completed

Started May 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

July 11, 2013

Last Update Submit

March 15, 2014

Conditions

Stable AnginaCoronary Stenosis

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    3 months

Study Arms (2)

Stent

ACTIVE COMPARATOR

drug eluting stent (Resolute)

Device: drug eluting stent

drug eluting balloon

EXPERIMENTAL

drug eluting balloon (Elutax)

Device: drug eluting balloon

Interventions

drug eluting balloonDEVICE
drug eluting balloon
drug eluting stentDEVICE
Stent

Eligibility Criteria

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

You may qualify if:

  • Patient ≥ 18years old
  • Stable angina symptoms
  • Elective treatment to coronary lesion
  • Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection

You may not qualify if:

  • Left main stem lesion
  • Bifurcation lesions
  • Acute coronary syndrome (UAP, NSTEMI, STEMI)
  • Cardiogenic shock
  • Chronic total occlusion
  • Additional lesions requiring PCI
  • Platelet count ≤ 50 x 109/mm3
  • Left ventricular ejection fraction ≤ 30%
  • Patient life expectancy less than 12 months
  • Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
  • Participation in another investigational drug or device study
  • Patient unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Angina, StableCoronary Stenosis

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary Disease

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, PhD

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 15, 2013

Study Start

May 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

DK(1)