NCT03269461

Brief Summary

Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

August 24, 2017

Last Update Submit

September 3, 2020

Conditions

Coronary Artery Disease

Keywords

stent, DES, INSPIRON, OCT, tissue repair

Outcome Measures

Primary Outcomes (1)

  • Tissue Coverage

    Change in the tissue coverage percentage measured by OCT

    3 months

Secondary Outcomes (3)

  • in-stent late lumen loss

    3 months

  • Stent Thrombosis

    2 years

  • Target Vessel Failure

    2 years

Study Arms (3)

30 days evaluation

EXPERIMENTAL

Angiography and Optical Coherence Tomography evaluations

Device: Angiography and Optical Coherence Tomography evaluations

2 months evaluation

EXPERIMENTAL

Angiography and Optical Coherence Tomography evaluations

Device: Angiography and Optical Coherence Tomography evaluations

3 months evaluation

EXPERIMENTAL

Angiography and Optical Coherence Tomography evaluations

Device: Angiography and Optical Coherence Tomography evaluations

Interventions

Angiography and Optical Coherence Tomography evaluationsDEVICE

coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

2 months evaluation3 months evaluation30 days evaluation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 and ≤ 80years;
  • Symptomatic CAD or documented myocardial ischemic disease;
  • Up to 2 de novo lesions on native coronary arteries;
  • Lesion length ≤ 29mm;
  • Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;
  • Stenose at target lesion ≥ 70% and ≤ 99%.

You may not qualify if:

  • STEMI within the last 72 hours pre-procedure;
  • renal insufficiency;
  • Left Main stenosis \> 50%;
  • Ostial lesions;
  • Bifurcation lesions with side branch ≥2mm;
  • More than one lesion \> 50% at the target vessel;
  • Left Ejection Fraction less than 30%;
  • Previous (less than 6 months) PCI at the target vessel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Evangélico do Espírito Santo

Vila Velha, Espírito Santo, Brazil

Location

Hospital do Coração Anis Rassi

Goiânia, Goiás, Brazil

Location

Paraná Medical Research Center

Maringá, Paraná, Brazil

Location

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDysequilibrium syndromeOrnithine Carbamoyltransferase Deficiency Disease

Interventions

Angiography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesUrea Cycle Disorders, InbornBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Cardiovascular

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 31, 2017

Study Start

October 2, 2017

Primary Completion

December 30, 2018

Study Completion

August 30, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(5)