Myocardial InfarctionAVIONCT00936169
Angiography Versus (vs) IVUS Optimisation
A study testing IVUS optimised DES implantation and angiographically guided DES implantation in people with Myocardial Infarction, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- IVUS optimised DES implantation and angiographically guided DES implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Age under 18 years old.
- There is no maximum number of lesions which can be treated
About this study
Official title: Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation
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
- Conditions
- Myocardial Infarction
- Being tested
- IVUS optimised DES implantation, angiographically guided DES implantation
- Keywords
- Patients with at least one complex lesion suitable for implantation of a drug-eluting stent
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS optimised DES implantationProcedure or surgery
Ivus optimised stent implantation
angiographically guided DES implantationProcedure or surgery
angiographically guided DES implantation
| Study group | Role | What they receive |
|---|---|---|
| IVUS optimised stent implantation | Experimental | Not described Receives: Procedure: IVUS optimised DES implantation |
| angiographically guided DES implantation | Active comparator | Not described Receives: Procedure: angiographically guided DES implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
Measured: Procedure day
Secondary outcomes (3)
Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group
Measured: 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.
Measured: 9 months
MACE events at 2 years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
- Sponsor type
- University, hospital or other
- Collaborators
- Mediolanum Cardio Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936169
- Sponsor's protocol ID
- AVIO
- Acronym
- AVIO
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23237135
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT00936169
- Acronym / sponsor ID
- AVIO / AVIO
- Conditions
- Myocardial Infarction
- Keywords
- Patients with at least one complex lesion suitable for implantation of a drug-eluting stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUSUniversity, hospital or other
- Collaborators
- Mediolanum Cardio Research
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS optimised stent implantation | Experimental | Procedure: IVUS optimised DES implantation |
| angiographically guided DES implantation | Active comparator | Procedure: angiographically guided DES implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUS optimised DES implantationIvus optimised stent implantation | Procedure or surgery | IVUS optimised stent implantation |
| angiographically guided DES implantationangiographically guided DES implantation | Procedure or surgery | angiographically guided DES implantation |
Primary outcome
Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
Time frame: Procedure day
3 secondary outcomes
Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group
Time frame: 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.
Time frame: 9 months
MACE events at 2 years.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Derived from this study: PubMed 23237135Chieffo 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.
Related trials for Myocardial Infarction
RecruitingObservational study
Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation
Atrial Fibrillation (AF)
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Not yet recruitingPhase 3
Cilostazol for Prevention of Recurrent Stroke Trial
Stroke Recurrence, Myocardial Infarction
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS optimised DES implantation and angiographically guided DES implantation in people with Myocardial Infarction, run by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group. (time frame: Procedure day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00936169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.