Coronary Ostium Stenosis, Myonecrosis
Conditions
Keywords
periprocedural myonecrosis, procedure time, fluoroscopy time
Brief summary
The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. However, predilatation could eliminate SB ostial stenosis obviating need for further SB treatment after main vessel stent implantation. The aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and without SB predilatation.
Interventions
PROCEDURESB predilatation
Initial SB \[predilatation.
PROCEDURENo SB predilatation
Without SB predilatation
Sponsors
Medica Cor Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion Criteria * Subject at least 18 years of age. * Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm. * Target lesion(s) amenable for PCI with balloon angioplasty of the side branch. 2.
Exclusion criteria
* ST-segment elevation myocardial infarction (STEMI) * Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). * Subjects who refuse to give informed consent. * Subjects with left ventricle ejection fraction \<30% * Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy * Contraindications for 12 months double antiplatelet therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for rewiring SB | 24h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural myonecrosis | 24 h | — |
| MACE | 12 months | death, MI, TVR |
Countries
Bulgaria
Contacts
Primary ContactDobrin I Vassilev, MD, PhD
Outcome results
None listed