Coronary Stenosis Clinical Trial
— OCTOPUS-2Official title:
Fractional Flow Reserve - Guided Elective Coronary Angioplasty Using Paclitaxel - Eluting Balloons With Provisional Stent Implantation: A Phase 4 Feasibility Study With 6-Month Follow-up by Optical Coherence Tomography
We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Indication for elective PCI according to the guidelines of European Society of Cardiology, American Heart Association and American College of Cardiology - Age > 18 years, written consent - Native de novo coronary lesion suitable for angioplasty and OCT imaging Exclusion Criteria: - Pregnancy and breast feeding mother - Co-morbidity with an estimated life expectancy of < 50 % at 1 year - Scheduled major surgery in the next 6 months - Not able to give informed written consent or non-compliance - Participation in other PCI trial - Acute coronary syndromes and cardiogenic shock - Known allergy to aspirin, thienopyridines or against taxol derivates - Culprit lesion within the proximal 10 mm of the right or left coronary artery - Saphenous vein grafts - Estimated lesion length > 30 mm |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Jena, Heart Center, Division of Cardiology | Jena |
Lead Sponsor | Collaborator |
---|---|
University of Jena | B. Braun Melsungen AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cardiac death or acute myocardial infarction due to target vessel failure | Cardiac death or acute myocardial infarction occurring in the presence of occlusion or severe flow limitation of the treated vessel | 6 month | Yes |
Primary | Late lumen loss | Late lumen loss (LLL, expressed in mm) measured within the treated segment by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter (MLD) at the end of the interventional procedure and MLD at 6-month follow-up | 6 months | No |
Secondary | Vessel remodeling assessed by optical coherence tomography | Lumen and vessel measurements, neointimal proliferation, plaque composition and dissection healing within the treated vessel segment at 6 months assessed by optical coherence tomography (OCT) with 3D-reconstruction | 6 months | No |
Secondary | Net lumen gain | Net lumen gain (NLG, expressed in mm) measured by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter within the treated segment (MLD) at 6-month follow-up and MLD at the lesion site at baseline | 6 months | No |
Secondary | Need for revascularization of the treated vessel segment | Need for revascularization of the treated vessel segment (target lesion revascularization, TLR) driven either clinically or after 6-month angiographic follow-up | 6 months | No |
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