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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

Tracking Information
First Submitted Date March 5, 2018
First Posted Date March 20, 2018
Last Update Posted Date March 17, 2021
Actual Study Start Date September 3, 2018
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2018)
MACE (major cardiac events) [ Time Frame: 12 months ]
Major cardiac events (death, myocardial infarction, target vessel revascularization)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 19, 2018)
  • Acute success [ Time Frame: up to 24 hours ]
    Acute success measured by Angiography after stent implantation
  • Stent Thrombosis [ Time Frame: 24 months ]
    Stent Thrombosis rate
  • MACE [ Time Frame: 24 months ]
    Major cardiac events (death, myocardial infarction, target vessel revascularization)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
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.
Brief Summary Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition Coronary Artery Disease
Intervention Device: Angioplasty
Inspiron Drug Eluting stent implantation
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 16, 2021)
299
Original Estimated Enrollment
 (submitted: March 19, 2018)
500
Estimated Study Completion Date November 30, 2022
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03471234
Other Study ID Numbers SCI-CO-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Scitech Produtos Medicos Ltda
Study Sponsor Scitech Produtos Medicos Ltda
Collaborators Not Provided
Investigators Not Provided
PRS Account Scitech Produtos Medicos Ltda
Verification Date March 2021