AzTrials
AzTrials

Coronary Artery DiseasePhase 3INSPIRONNCT01093391

A Trial of Bare Metal Stent - Cobalt Chromium Versus Stent Coating With Sirolimus

A Phase 3 study testing DRUG ELUTING STENT and BARE METAL STENT in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 4 sites in Brazil.

Completed

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

Official record
Search all trials

Trial summary

The objective of this study is to evaluate the security issues and efficacy of coronary stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with coronary artery lesion. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Coronary Artery Disease
What is being tested?
DRUG ELUTING STENT and BARE METAL STENT
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
4 sitesBrazil
Study dates
Nov 2010to Jul 2015
Phase
Phase 3
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years and ≤75 years;
  • Symptomatic cardiac ischemic disease and/or documented evidence of myocardial ischemia;
  • Types B1 and B2 coronary lesions (according to the ACC/AHA classification modified by Ellis);
  • Target lesion located in a native coronary artery;
  • Target lesion in vessel with diameter ranging from 2.5 to 3.5 mm (by visual estimate) amenable to treatment (coverage) with a 16- 19mm-long stent;
  • Target lesion with >50% diameter stenosis (by visual estimate);
  • Acceptable candidate to myocardial revascularization surgery (coronary artery bypass graft surgery);
  • The subject has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.

Who cannot join

  • Female patients of childbearing potential;
  • Recent Q-wave myocardial infarction occurred within 48 hours prior to the index procedure. Recent Q-wave or non-Q-wave myocardial infarction with still elevated levels of cardiac markers;
  • Documented left ventricular ejection fraction <30%;
  • Renal dysfunction (creatinine > 2.0 mg/dL or 177 µmol/L);
  • Platelet count <100,000 cells/mm³ or >700,000 cells/mm³.;
  • White blood cell count <3,000 cells/mm3;
Show all 27Show fewer
  • Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
  • Heart transplant receptor;
  • Known hypersensitivity to cobalt-chromium or to medications such as aspirin, clopidogrel bisulfate (Plavix or ISCOVER), ticlopidine (Ticlid) or heparin.
  • Concurrent medical condition with a life expectancy of less than 12 months;
  • Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient in this study;
  • Subject is currently participating in an investigational drug or another device study, including planned participation in an investigational drug or another device study during the course of the present investigation;
  • Coronary angioplasty (with or without stenting) less than 9 months before the index procedure at any site of the target vessel;
  • Previous coronary angioplasty (with or without stenting) at any time (>9 months) in a vessel segment less than 5 mm proximal or distal to the target lesion.
  • Planned coronary angioplasty (with or without stenting) in the first 12 months after the index procedure in any segment of the target vessel;
  • 4.3. ANGIOGRAPHIC EXCLUSION CRITERIA
  • Restenotic target lesion;
  • More than one lesion requiring treatment in the same vessel;
  • Target vessel diameter <2.5 mm or >3.5 mm (by visual estimation);
  • Long target lesion not amenable to treatment (coverage) with a 16-19mm long stent;
  • Unprotected coronary artery branch lesion (≥50% diameter stenosis)
  • Target lesion is located in a surgical bypass graft;
  • Total vessel occlusion (TIMI flow grade 0-1);
  • Target lesion with ostial location;
  • Target lesion located in a lateral branch bifurcation >2.5mm or requiring lateral branch stenting;
  • Calcified target lesion that anticipates unsuccessful/impracticable predilation;
  • Target vessel with excessive tortuosity

Trial locations and contacts

4 sites in 1 country.

Brazil4 sites

  • Hospital Ibiapaba de Barbacena

    Barbacena, Minas Gerais, 36201-356

  • Instituto de Assistêcia Médica ao Servidor Publico Estadual

    São Paulo, São Paulo, 04029-000

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

    São Paulo, São Paulo, 05403-000

  • Hospital Santa Marcelina

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

About this study

Official title: A Randomized Trial of Bare Metal Stent (Cronus®) - Cobalt Chromium Versus Stent Coating With Sirolimus (DES)

The objective of this study is to evaluate the security issues and efficacy of coronary stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with coronary artery lesion.

Read the detailed description

Patients will be treated in compliance with the eligibility criteria, with stent study of 16-19mm. All patients are clinically followed for 60 months after the procedure and will undergo a control angiography 6 months. Can be treated multiple lesions, measuring between 2.5-3.5mm (by visual estimate). Patients enrolled will be randomized in a 1:2 propose in one of the groups with or without stent coating, respectively. And a randomized clinical trial, prospective study in 5 centers including 60 patients.

Being tested
DRUG ELUTING STENT, BARE METAL STENT
Keywords
coronary artery, thrombosis, stent
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.

  • DRUG ELUTING STENTDevice

    Also called Angiography, Stenting

    Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.

  • BARE METAL STENTDevice

    Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.

Study groups in NCT01093391
Study groupRoleWhat they receive
BARE METAL STENTPlacebo comparatorBARE METAL STENT - STENT CRONUS
Receives: Device: BARE METAL STENT
DRUG ELUTING STENTExperimentalSTENT INSPIRON WITH SIROLIMUS
Receives: Device: DRUG ELUTING 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 6 months after implantation, a follow-up catheterization will be performed at the 6-month visit in order to measure the diameter of the artery at the stented site. The objective is the lumen loss in-segment (including the portion in-stent and edges of 5 mm proximal and distal) at 6 months.

    Measured: 6 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, 6, 12 and 60 months post-procedure, and should consist of an assessment of the angina status (according to the Canadian Cardiovascular Society Classification and the Braunwald Classification for unstable angina) and major adverse cardiac events and any interventional treatment (e.g.: repeated target lesion revascularization or recurrent ischemia).

    Measured: 30 days, 6, 12 and 60 months 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 posted25 Mar 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJul 2015
  4. Study completionJul 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093391
Sponsor's protocol ID
Scitech 001
Acronym
INSPIRON
Status last verified
Jul 2015
First submitted
18 Mar 2010
Last updated
22 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Carlos Augusto Homem de Magalhães Campos; Celso K. Takimura; Guilherme B. Gregores; Carlos A. Sarmento; Emerson T. Fioretto; Fracisco R. M. Laurindo; Expedito E. Ribeiro; Eulógio E. Martinez; Thiago F.C.C. Borges; Pedro A. Lemos. Redução neointimal com Stent com polímero biodegradável e Sirolimus desenvolvido no Brasil: Resultados preliminares em Suínos. Rev. Soc. Cardiol. Estado de São Paulo - Supl. B - Vol. 19

  • Oliveira MD, Ribeiro EE, Campos CM, Ribeiro HB, Faillace BL, Lopes AC, Esper RB, Meirelles GX, Perin MA, Abizaid A, Lemos PA. Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial. Cardiovasc Diagn Ther. 2015 Aug;5(4):264-70. doi: 10.3978/j.issn.2223-3652.2015.07.05.

    PubMed 26331110

  • Ribeiro EE, Campos CM, Ribeiro HB, Lopes AC, Esper RB, Meirelles GX, Perin MA, Abizaid A, Lemos PA. First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial. EuroIntervention. 2014;9(12):1380-4. doi: 10.4244/EIJV9I12A234.

    PubMed 24755382

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DRUG ELUTING STENT and BARE METAL STENT in people with Coronary Artery Disease, run by Scitech Produtos Medicos SA at 4 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 8 inclusion and 27 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 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: 6 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 NCT01093391, which also lists 3 linked publications.

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 Jul 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in