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Coronary Artery DiseasePhase 4NCT01856088

DESTINY TRIAL (Inspiron x Biomatrix)

A Phase 4 study testing Inspiron Stent and Biomatrix Flex Stent in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 10 sites in Brazil.

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 main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteries. 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?
Inspiron Stent and Biomatrix Flex Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
10 sitesBrazil
Study dates
May 2013to 21 Mar 2019
Phase
Phase 4
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

  • Age > 18 years;
  • Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels;
  • A(s) lesion(s) to target(m) must be:
  • Again (not restenotic);
  • Located in a native coronary artery diameter from 2.5 to 3.5 mm (visual);
  • Can be treated with a single stent up to 29 mm in length;
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  • Obstruction with stenosis > 50% diameter (visual);
  • Acceptable candidate for CABG;
  • The patient will be informed of the nature of the study, agree with their rules and provide a written informed consent approved by the local Ethics Committee.

Who cannot join

  • Women of childbearing age with no history of surgical sterilization;
  • Myocardial infarction with Q wave occurred in the last 48 hours before the index procedure;
  • Myocardial infarction with or without Q wave with cardiac markers even at high levels;
  • Ejection fraction < 30%;
  • Impaired renal function (creatinine> 2.0 mg / dl) or calculated creatinine clearance < 60 ml / min;
  • Platelet count <100,000 cells/mm3 or > 700,000 cells/mm3;
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  • Total leukocyte count <3000 cells/mm3;
  • Documented or suspected liver disease (including laboratory evidence of hepatitis);
  • Heart transplant recipient;
  • Known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel;
  • Patient with a life expectancy less than 12 months;
  • Any significant medical condition which in the opinion of the investigator would interfere with the ideal of patient participation in this study;
  • Participation in other research in the last 12 months, unless there is direct benefit to the research subject;
  • Coronary angioplasty (with or without stenting) for less than 6 months anywhere in the target vessel;
  • Coronary angioplasty (with or without stenting) prior to any time in that segment Diste less than 5 mm (proximal or distal) of the lesion;
  • Coronary angioplasty (with or without stenting) scheduled in the first 12 months after the index procedure in any segment of the target vessel.
  • Restenotic target lesion;
  • Need for treatment for more than one lesion in the same vessel;
  • Need for treatment with three or more lesions in the same procedure;
  • Target vessel diameter <2.5 mm or> 3.5 mm (visual);
  • Target lesion long not susceptible to treatment with a single stent to 29mm in length, according to the judgment of the operator;
  • Lesion of the coronary artery unprotected ( > 50% stenosis);
  • Angiographic thrombus;
  • Target lesion in surgical graft;
  • Total occlusion (TIMI anterograde flow 0 or 1);
  • Ostial lesion;
  • The target lesion bifurcation with side branch that may require intervention during the procedure, with or without stenting;
  • Injuries that are impossible to anticipate predilatation successfully or that is necessary to use rotablator;
  • The target vessel with excessive tortuosity.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Brazil10 sites

  • Hospital Cardiologico Costantini

    Curitiba, Paraná

  • Encore - Cardiologia e Radiologia Intervencionista

    Goiânia, Goiás

  • Instituto de Cardiologia do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul

  • Hospital Santa Izabel

    Salvador, Estado de Bahia

  • Hospital Bandeirantes de São Paulo

    São Paulo, São Paulo

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, São Paulo

  • Instituto de Assistência Médica ao Servidor Publico Estadual

    São Paulo, São Paulo

  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, São Paulo

  • Santa Casa de Misericórdia de São Paulo

    São Paulo, São Paulo

  • Hospital Santa Marcelina

    São Paulo

Other trials in Brazil

About this study

Official title: Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - Destiny Trial

The main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteries.

Read the detailed description

This is a study of non-inferiority, multicentre, prospective, randomized into two treatment arms: I) Inspiron ™ stent eluting sirolimus or II) ™ Biomatrix stent eluting biolimus. Are a total of 165 randomized patients.

Patients will be followed for 60 months after the procedure. All new patients will be undergoing angiography for evaluation at 9 months. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months. It is anticipated that the total study duration is 72 months: 12 months to complete the admission of patients and 60 months of follow-up.

Being tested
Inspiron Stent, Biomatrix Flex Stent
Keywords
Coronary artery, Drug eluting stent, thrombosis
Medical subject headings
Coronary Artery Disease, Thrombosis

What participants receive

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

  • Inspiron StentDevice

    Also called Angioplasty

    stent implantation

  • Biomatrix Flex StentDevice

    Also called Angioplasty

    stent implantation

Study groups in NCT01856088
Study groupRoleWhat they receive
Inspiron StentExperimentalStent Inspiron with Sirolimus
Receives: Device: Inspiron Stent
Biomatrix Flex StentActive comparatorStent Biomatrix Flex with biolimus
Receives: Device: Biomatrix Flex Stent

What is being measured

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

  1. Lumen Loss

    For an accurate assessment of the stent conditions 9 months after implantation, a follow-up catheterization will be performed at the 9 months visit in order to measure the diameter of the artery at the stented site.

    A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months.

    Measured: 9 months after the procedure

Secondary outcomes (1)

  1. Adverse Cardiac Events

    The clinical follow-up should be performed during the index procedure at 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure, and should consist of an assessment of the angina status (according to the Canadian Cardiovascular Society Classification and the Braunwald for unstable angina) and major adverse cardiac avents and any interventional treatment (e.g: repeated targetlesion revascularization or recurrent ischemia)

    Measured: 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.

Timeline

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

  1. First posted17 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionSep 2014
  4. Study completion21 Mar 2019

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01856088
Sponsor's protocol ID
Scitech 004
Status last verified
Apr 2018
First submitted
27 Dec 2012
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Lemos PA, Abizaid AA, Meireles GC, Sarmento-Leite R, Prudente M, Cantarelli M, Dourado AD, Mariani J Jr, Perin MA, Costantini C, Costa RA, Costa JR, Chamie D, Campos CA, Ribeiro E. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial. Cardiovasc Ther. 2015 Dec;33(6):367-71. doi: 10.1111/1755-5922.12159.

    PubMed 26352896

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inspiron Stent and Biomatrix Flex Stent in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 10 sites in Brazil.

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 9 inclusion and 29 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Lumen Loss (time frame: 9 months after the procedure). 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 NCT01856088, 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 25 Mar 2019.

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