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Coronary Artery DiseasePhase 1NCT00596661

The TRIMAXX Coronary Stent Trial

A Phase 1 study testing TriMaxx Coronary Stent placement in people with Coronary Artery Disease, run by Abbott Medical Devices at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the TRIMAXX Coronary stent system as compared to the reported results for commercially available non-drug eluting coronary stent systems which are indicated… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
TriMaxx Coronary Stent placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesin 2 countries
Study dates
May 2004to Sep 2005
Phase
Phase 1
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

  • Eligible for catheter based treatment
  • Single coronary lesion requiring treatment
  • Lesion is accessible with stent device
  • Completes informed consent for participation
  • Stable condition (no symptoms of heart attack within 72 hours prior to treatment)

Who cannot join

  • Normal lab values
  • Previous treatment in the affected artery

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Brazil2 sites

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo

  • Instituto Do Coracao do Triangolo Mineiro

    Uberlândia

Other trials in Brazil

Germany1 site

  • Johannes Gutenberg Universitat

    Mainz

Other trials in Germany

About this study

Official title: A Prospective, Multi-Center, Non-Randomized, Single-Arm Trial to Evaluate the Safety and Feasibility of the TriMaxx Coronary Stent in de Novo Coronary Artery Lesions.

The primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the TRIMAXX Coronary stent system as compared to the reported results for commercially available non-drug eluting coronary stent systems which are indicated for the same treatments.

Read the detailed description

The TriMaxx study is a prospective, multicenter, non-randomized, single-arm trial intended to demonstrate the safety and feasibility of the TriMaxx Cornary Stent System. The study will enroll 100 subjects with de novo native coronary artery lesions who meet the eligibility criteria and agree to participate in the study. Subjects will be enrolled in a sequential manner. The safety and feasibility of the TRIMAXX stent will be evaluated by comparing the MACE rate that is observed 30 days post-procedure to the MACE rate for commercially available non-drug eluting stents. Secoandry evaluations will include analysis of clinical and angiographic parameters at 6 months. All subjects will undergo assessments at 30 days and at 6 months. Additionally, all subjects will undergo a follow-up angiogram at 6 months.

Being tested
TriMaxx Coronary Stent placement
Keywords
coronary stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TriMaxx Coronary Stent placementDevice

    Also called TriMaxx™ Coronary Stent

    Angioplasty with coronary artery stent placement

Study groups in NCT00596661
Study groupRoleWhat they receive
TRIMAXXExperimentalTRIMAXX Coronary Stent
Receives: Device: TriMaxx Coronary Stent placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR)

    Measured: 30 Days

Secondary outcomes (10)

  1. Clinical Outcome: MACE

    Measured: 6 months

  2. Clinical Outcome: Ischemia driven TVR

    Measured: 6 months

  3. Clinical Outcome: Ischemia driven Target LesionRevascularization(TLR)

    Measured: 6 months

  4. Clinical Outcome: Target Vessel Failure(TVF)

    Measured: 6 months

  5. Angiographic Outcome: Device Success defined as achievment of a final residual in-stent stenosis > 30%(by QCA) using the assigned device only

    Measured: procedural

  6. Angiographic Outcome: Lesion Success defined as attainment of a >30% residual in-stent stenosis (by QCA) using any percutaneous method

    Measured: procedural

  7. Angiographic Outcome: Procedural Success without the occurrence of cardiac death, Q-wave or Non Q-wave MI or repeat revascularization of the target lesion during the hospital stay.

    Measured: hospital stay

  8. Angiographic Outcome: Angiographic in-stent and in-segment binary restenosis rate(>/= 50% diameter stenosis)

    Measured: at 6 months

  9. Angiographic Outcome: In-stent, in-segment, proximal, and distal minimum lumen diameter(MLD))

    Measured: at 6 months

  10. Angiographic Outcome: Angiographic in-stent late loss, defined as the difference between the post-procedural MLD and the follow-up MLD

    Measured: at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2008 (estimated)
  2. Study startMay 2004
  3. Primary completionSep 2005
  4. Study completionSep 2005

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00596661
Sponsor's protocol ID
AVD 640-0051-01
Status last verified
Oct 2008
First submitted
9 Jan 2008
Last updated
15 Oct 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Abizaid A, Popma JJ, Tanajura LF, Hattori K, Solberg B, Larracas C, Feres F, Costa Jde R Jr, Schwartz LB. Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent: the TriMaxx trial. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):914-9. doi: 10.1002/ccd.21279.

    PubMed 18044791

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TriMaxx Coronary Stent placement in people with Coronary Artery Disease, run by Abbott Medical Devices at 3 sites in 2 countries.

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 5 inclusion and 2 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 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Major Adverse Cardiac Events(MACE). MACE defined as Cardiac Death, MI(Q-wave and Non Q-wave) and Rarget Vessel Revascularization (TVR) (time frame: 30 Days). 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 NCT00596661, 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 15 Oct 2008.

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