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

NCT01056744 | Completed Phase 4 DMC

• 1 other identifier: UKJ-TCP-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

coronary stent; optical coherence tomography; drug-eluting; neointimal proliferation

Outcome Measures

Primary Outcomes (1)

• Endothelial coverage of the stent struts assessed by optical coherence tomography

  6 months

Secondary Outcomes (3)

• Neointimal proliferation within the stent assessed by optical coherence tomography

  6 months

• Subacute or late thrombosis of the study stent

  6 months

• Need for revascularization of the vessel segment containing the study stent

  6 months

Study Arms (2)

DES

ACTIVE COMPARATOR

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

Device: Percutaneous coronary intervention with stent implantation

BMS/DEB

ACTIVE COMPARATOR

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

Interventions

Percutaneous coronary intervention with stent implantation 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)

Also known as: XIENCE® V, Coroflex Blue®, Sequent Please®

BMS/DEB; DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead
• B. Braun Melsungen AG: collaborator
• Abbott Medical Devices: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

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

Jena, 07740, Germany

Location

Related Publications (2)

• 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.

  PMID: 25371536 DERIVED

• 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.

  PMID: 22027737 DERIVED

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Tudor C Poerner, MD, PhD

  Jena University Hospital

  STUDY DIRECTOR

• Hans R Figulla, Professor

  Jena University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2012
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

DE (1)