Status:
COMPLETED
Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
Lead Sponsor:
Scitech Produtos Medicos Ltda
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Detailed Description
The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 mo...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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.
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03269461
Start Date
October 2 2017
End Date
August 30 2020
Last Update
September 4 2020
Active Locations (5)
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1
Hospital Evangélico do Espírito Santo
Vila Velha, Espírito Santo, Brazil
2
Hospital do Coração Anis Rassi
Goiânia, Goiás, Brazil
3
Paraná Medical Research Center
Maringá, Paraná, Brazil
4
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil