Coronary Ostium Stenosis Clinical Trial
— SBPSOfficial title:
Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | May 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Medica Cor Heart Hospital | Ruse |
| Lead Sponsor | Collaborator |
|---|---|
| Medica Cor Heart Hospital |
Bulgaria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time for rewiring SB | 24h | Yes | |
| Secondary | Periprocedural myonecrosis | 24 h | Yes | |
| Secondary | MACE | death, MI, TVR | 12 months | Yes |