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

NCT ID: NCT01056744

Last Updated: 2013-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-06-30

Brief Summary

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%.

Conditions

Stents; Neointimal Proliferation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DES

Implantation of a XIENCE® V everolimus eluting coronary stent (drug-eluting stent, DES)

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention with stent implantation

Intervention Type: DEVICE

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)

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)

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention with stent implantation

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

XIENCE® V, Coroflex Blue®, Sequent Please®

Eligibility 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

• 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
• Previous subacute or late coronary stent thrombosis
• Known non-responsiveness / allergy to aspirin or thienopyridines
• Known allergy against everolimus or against taxol derivates

• Culprit lesion within the proximal 10 mm of the right or left coronary artery
• Saphenous vein grafts
• Estimated stent length > 30 mm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

Tudor C. Poerner

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tudor C Poerner, MD, PhD

Role: STUDY_DIRECTOR

Jena University Hospital

Hans R Figulla, Professor

Role: STUDY_CHAIR

Jena University Hospital

Locations

University Hospital of Jena, 1st Medical Department, Division of Cardiology

Jena, , Germany

Countries

Germany

References

Poerner TC, Otto S, Gassdorf J, Nitsche K, Janiak F, Scheller B, Goebel B, Jung C, Figulla HR. Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up. Circ Cardiovasc Interv. 2014 Dec;7(6):760-7. doi: 10.1161/CIRCINTERVENTIONS.113.001146. Epub 2014 Nov 4.

Reference Type: DERIVED

PMID: 25371536 (View on PubMed)

Poerner TC, Otto S, Gassdorf J, Janiak F, Danzer C, Ferrari M, Figulla HR. A prospective randomised study using optical coherence tomography to assess endothelial 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 (OCTOPUS Trial): rationale, design and methods. EuroIntervention. 2011 May;7 Suppl K:K93-9. doi: 10.4244/EIJV7SKA16.

Reference Type: DERIVED

PMID: 22027737 (View on PubMed)

Other Identifiers

UKJ-TCP-1

Identifier Type: -

Identifier Source: org_study_id