Status:
COMPLETED
Evaluation of the Neointimal Healing by OCT of the Tapered DES Biomime Morph (TAPER-I Study)
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The long and very long stents, although they represent a greater navigability challenge, especially in tortuous and calcified coronary arteries, they have the advantage of providing shorter procedural...
Eligibility Criteria
Inclusion
- General clinical criteria
- Both gender with age ≥ 18 years
- Clinical indication for a PCI with a DES due to an acute coronary syndrome for unstable angina or non-ST elevation myocardial infarction (NSTEMI), stable angina, or in asymptomatic patients with objective evidence of ischemia.
- Included patients must have all inclusion criteria and provide written informed consent.
- Angiographic criteria
- Lesions with a length ≥ 30 mm, amenable for the treatment with only one stent
- Up to 2 "de novo" lesions/patients in native vessels
- Vessel diameter between 2.5 and 4 mm.
Exclusion
- General clinical exclusion criteria
- Previous use of brachytherapy or a stent in the target vessel;
- Left ventricular ejection fraction \<25%;
- bleeding diathesis;
- Contraindication to aspirin or P2Y12 inhibitors, heparina or any component of the DES.
- Creatinine levels \> 2.0mg/dl;
- Leucocyte count \< 3.500 céls/mm3;
- Platelet count \< 100.000 céls/mm³
- Pregnancy;
- Surgical procedure scheduled within the next 6 months, except if DAPT could be maintained;
- Impossibility to provide written informed consent.
- Angiographic Criteria
- Left main disease \> 50%;
- Bifurcation lesions with side branch \> 2.0mm in diameter where a stent should be required in the side branch (2-stent technique);
- Occluded vessel (Thrombolysis in Myocardial Infaction grade 0 /1)
- Restenosis;
- Saphenous vein graft and LIMA.
Key Trial Info
Start Date :
November 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04805619
Start Date
November 7 2019
End Date
December 8 2021
Last Update
May 25 2022
Active Locations (1)
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1
Instituto do Coração - HCFMUSP
São Paulo, Brazil, 05403-900