Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Optical Coherence Tomography to Evaluate Paclitaxel-Eluting Balloons and Everolimus-Eluting Coronary Stents (OCTOPUS)

This study has been completed.
Sponsor:
Collaborators:
B. Braun Melsungen AG
Abbott Vascular
Boston Scientific Corporation
Information provided by (Responsible Party):
Tudor C. Poerner, University of Jena
ClinicalTrials.gov Identifier:
NCT01056744
First received: January 25, 2010
Last updated: February 25, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Endothelial coverage of the stent struts assessed by optical coherence tomography [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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:

  1. 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
  2. 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
  3. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056744

Locations
Germany
University Hospital of Jena, 1st Medical Department, Division of Cardiology
Jena, Germany, 07740
Sponsors and Collaborators
University of Jena
B. Braun Melsungen AG
Abbott Vascular
Boston Scientific Corporation
Investigators
Study Director: Tudor C Poerner, MD, PhD Jena University Hospital
Study Chair: Hans R Figulla, Professor Jena University Hospital
  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
Paclitaxel
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014