NCT00936169

Brief Summary

The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions

Trial Health

100
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

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

May 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 22, 2012

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

July 8, 2009

Last Update Submit

February 20, 2012

Conditions

Myocardial Infarction

Keywords

Patients with at least one complex lesion suitable for implantation of a drug-eluting stent

Outcome Measures

Primary Outcomes (1)

  • Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.

    Procedure day

Secondary Outcomes (3)

  • Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group

    9 months

  • Major adverse cardiac events (MACE) at 9 months: superiority or statistical trend for the IVUS guided group due to lower TLR and no difference in myocardial infarction (MI) or death.

    9 months

  • MACE events at 2 years.

    2 years

Study Arms (2)

IVUS optimised stent implantation

EXPERIMENTAL
Procedure: IVUS optimised DES implantation

angiographically guided DES implantation

ACTIVE COMPARATOR
Procedure: angiographically guided DES implantation

Interventions

IVUS optimised DES implantationPROCEDURE

Ivus optimised stent implantation

IVUS optimised stent implantation
angiographically guided DES implantationPROCEDURE

angiographically guided DES implantation

angiographically guided DES implantation

Eligibility Criteria

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

You may qualify if:

  • A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion

You may not qualify if:

  • Contra-indication to dual anti-platelet therapy.
  • Ejection fraction \<30%.
  • Renal failure (creatinine \>2 mg/dL).
  • Significant co-morbidity precluding clinical follow-up.
  • Acute myocardial infarction in the 48 hours prior to the procedure.
  • In-stent restenosis
  • Prior brachytherapy
  • Thrombocytopenia \<100,000
  • Unprotected left main stem stenosis
  • Venous or arterial grafts
  • Recipient of heart transplant
  • A positive pregnancy test in women with child bearing potential
  • Acute infections
  • Major surgery planned which will lead to discontinuation of antiplatelet therapy
  • Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chieffo A, Latib A, Caussin C, Presbitero P, Galli S, Menozzi A, Varbella F, Mauri F, Valgimigli M, Arampatzis C, Sabate M, Erglis A, Reimers B, Airoldi F, Laine M, Palop RL, Mikhail G, Maccarthy P, Romeo F, Colombo A. A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial. Am Heart J. 2013 Jan;165(1):65-72. doi: 10.1016/j.ahj.2012.09.017. Epub 2012 Nov 20.

    PMID: 23237135DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 9, 2009

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Study Completion

July 1, 2011

Last Updated

February 22, 2012

Record last verified: 2009-07