Optical Coherence Tomography to Evaluate Paclitaxel-Eluting Balloons and Everolimus-Eluting Coronary Stents (OCTOPUS)
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Purpose
Background:
Safety concerns regarding use of drug eluting stent systems (DES) are related mostly to late stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific information about time course and amount of endothelial strut coverage of different DES is required, in order to further refine the concept of antiplatelet therapy after DES implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal proliferation. Very limited OCT data about endothelial coverage of DES are currently available. Aim of this study is a comparative evaluation of XIENCE V® everolimus eluting stent (Abbot Vascular) and of the bare metal stent (BMS) Coroflex® Blue postdilated with the drug-eluting balloon (DEB) SeQuent® Please (paclitaxel-eluting balloon, B. Braun Melsungen AG) in terms of endothelial coverage and neointimal proliferation using OCT.
Study Design:
A number of 80 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either XIENCE V® or Coroflex® Blue/Sequent® Please. The study is prospectively conducted at a university high-volume PCI center with OCT expertise (Jena, Germany). Angiographic follow-up and OCT imaging with motorized pull-back at 1 mm/s are planned in all patients 6 months after implantation of the study stents. OCT endpoints are: (1) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts, and respectively (2) neointimal proliferation, given as % neointimal volumetric proliferation within the whole stent and also as focal peak % neointimal area proliferation. The study is not powered for clinical endpoints, which are: subacute or late stent thrombosis and need for revascularization of the stent segment. Given the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up to 20%.
| Condition | Intervention | Phase |
|---|---|---|
|
Stents Neointimal Proliferation |
Device: Percutaneous coronary intervention with stent implantation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Endothelial Stent Coverage and Neointimal Proliferation at 6 Months After Implantation of a Coronary Everolimus-Eluting Stent Compared With a Bare Metal Stent Postdilated With a Paclitaxel-Eluting Balloon: A Randomised Study Using Optical Coherence Tomography |
- Endothelial coverage of the stent struts assessed by optical coherence tomography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Neointimal proliferation within the stent assessed by optical coherence tomography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Subacute or late thrombosis of the study stent [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Need for revascularization of the vessel segment containing the study stent [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 90 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: DES
Implantation of a XIENCE® V everolimus eluting coronary stent (drug-eluting stent, DES)
|
Device: Percutaneous coronary intervention with stent implantation
Percutaneous coronary intervention with implantation of either: - a XIENCE® V everolimus eluting coronary stent in one of the following sizes: 3.0 x 18 mm, 3.0 x 28 mm, 2.5 x 18 mm, 2.5 x 28 mm (DES group), or: - a Coroflex Blue® coronary stent postdilated with a Sequent Please® paclitaxel-eluting balloon in one of the following size combinations (stent / balloon): 3.0 x 16 mm / 3.0 x 20 mm, 3.0 x 25 mm / 3.0 x 30 mm, 2.5 x 16 mm / 2.5 x 20 mm, 2.5 x 25 mm / 2.5 x 30 mm (BMS/DEB group) Other Name: XIENCE® V, Coroflex Blue®, Sequent Please®
|
|
Active Comparator: BMS/DEB
Implantation of a Coroflex Blue® coronary stent (bare metal stent, BMS) postdilated with a Sequent Please® paclitaxel-eluting balloon (drug-eluting balloon, DEB)
|
Device: Percutaneous coronary intervention with stent implantation
Percutaneous coronary intervention with implantation of either: - a XIENCE® V everolimus eluting coronary stent in one of the following sizes: 3.0 x 18 mm, 3.0 x 28 mm, 2.5 x 18 mm, 2.5 x 28 mm (DES group), or: - a Coroflex Blue® coronary stent postdilated with a Sequent Please® paclitaxel-eluting balloon in one of the following size combinations (stent / balloon): 3.0 x 16 mm / 3.0 x 20 mm, 3.0 x 25 mm / 3.0 x 30 mm, 2.5 x 16 mm / 2.5 x 20 mm, 2.5 x 25 mm / 2.5 x 30 mm (BMS/DEB group) Other Name: XIENCE® V, Coroflex Blue®, Sequent Please®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology
- Age > 18 years, written consent
- Native coronary lesion suitable for stent placement and OCT imaging
Exclusion Criteria:
General 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
Procedural exclusion criteria:
- Acute coronary syndromes and cardiogenic shock
- Previous subacute or late coronary stent thrombosis
- Known non-responsiveness / allergy to aspirin or thienopyridines
- Known allergy against everolimus or against taxol derivates
Angiographic exclusion criteria:
- Culprit lesion within the proximal 10 mm of the right or left coronary artery
- Saphenous vein grafts
- Estimated stent length > 30 mm
Contacts and Locations| Germany | |
| University Hospital of Jena, 1st Medical Department, Division of Cardiology | |
| Jena, Germany, 07740 | |
| Study Director: | Tudor C Poerner, MD, PhD | University Hospital of Jena |
| Study Chair: | Hans R Figulla, Professor | University Hospital of Jena |
More Information
No publications provided by University of Jena
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tudor C. Poerner, PD Dr. med., University of Jena |
| ClinicalTrials.gov Identifier: | NCT01056744 History of Changes |
| Other Study ID Numbers: | UKJ-TCP-1 |
| Study First Received: | January 25, 2010 |
| Last Updated: | February 25, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Jena:
|
coronary stent optical coherence tomography drug-eluting neointimal proliferation |
Additional relevant MeSH terms:
|
Everolimus Sirolimus Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013