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Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE (LATITUDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03471234
Recruitment Status : Active, not recruiting
First Posted : March 20, 2018
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda

Brief Summary:
Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Angioplasty

Detailed Description:
Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 299 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: LATIn American sTUdy to Investigate the Clinical Performance of Sirolimus-eluting Stent With Abluminal-only bioDEgradable Polymeric Coating (Inspiron TM) in the Treatment of Native Coronary Artery Lesions.
Actual Study Start Date : September 3, 2018
Actual Primary Completion Date : October 30, 2020
Estimated Study Completion Date : November 30, 2022

Intervention Details:
  • Device: Angioplasty
    Inspiron Drug Eluting stent implantation


Primary Outcome Measures :
  1. MACE (major cardiac events) [ Time Frame: 12 months ]
    Major cardiac events (death, myocardial infarction, target vessel revascularization)


Secondary Outcome Measures :
  1. Acute success [ Time Frame: up to 24 hours ]
    Acute success measured by Angiography after stent implantation

  2. Stent Thrombosis [ Time Frame: 24 months ]
    Stent Thrombosis rate

  3. MACE [ Time Frame: 24 months ]
    Major cardiac events (death, myocardial infarction, target vessel revascularization)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lesions in native coronary arteries measuring between 2.5 and 4.0 mm in diameter and 34 mm length treated only with Inspiron Sirolimus-Eluting Stent.
Criteria

Inclusion Criteria:

  • All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.

Exclusion Criteria:

  • Saphenous vein grafts or Mammary lesions;
  • Individuals who have been treated within the last 6 months with another stent;
  • Acute myocardial infarction with ST segment elevation;
  • Chronic Total Occlusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471234


Locations
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Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Instituto do Coração - INCOR
São Paulo, Brazil
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
Additional Information:

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Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT03471234    
Other Study ID Numbers: SCI-CO-01
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scitech Produtos Medicos Ltda:
coronary disease
drug eluting stent
Inspiron
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases