Evaluation of HealinG of Polymer-Free Biomlimus A9-Coated Stent by Optical Coherence Tomography (EGO-BIOFREEDOM)

NCT01760876 | Completed Results DMC

• 1 other identifier: UW 12-454
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Since polymers have been identified as a possible cause of late complications of drug eluting stents, new stents are being designed to improve polymers' biocompatibility or to bond drugs on stents without polymers. Biolimus A9 is the therapeutic agent used in the BioFreedom drug coated stent. Biolimus A9 is a proprietary semi-synthetic sirolimus derivative. It is highly lipophilic, rapidly absorbed in tissues, and able to reversibly inhibit growth factor-stimulated cell proliferation. In this study, we use intracoronary optical coherence tomography (OCT) to evaluate the BioFreedom Stents after implantation regarding endovascular healing over time as primary objective; and also to evaluate secondary OCT, angiographic and clinical outcomes at various specific time points.

Conditions

Coronary Disease

Keywords

Optical Coherence Tomography; Biofreedom Stent

Outcome Measures

Primary Outcomes (1)

• OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months.

  The percentage of strut coverage and category of coverage (A to F) from 1 month to 9 months by longitudinal sequential OCT assessments. A. Definitely uncovered - strut not covered by tissue, and both sides appear square; B. Uncovered with abnormal in-stent tissue - strut covered by irregular tissue or fibrin, and both sides appear square; C. Partially uncovered - strut partially covered by tissue but only one side has a smooth continuous shoulder; D. Covered (protruding) - strut covered by thin continuous tissue on both sides but still extending into the lumen; E. Covered (embedded) - strut covered by continuous tissue or neointima and not interrupting the smooth lumen contour; F. Covered (proliferative) - strut covered with excessive growth of neointima with thickness \>0.3 mm.

  1 to 9 months

Secondary Outcomes (1)

• OCT Endpoints (Neointimal Metrics), QCA Endpoints (Late Lumen Loss at 9 Months), and Clinical Endpoints (MACE at 9 Months and 12 Months). A Subgroup Analysis Would be Performed for Diabetic Patients.

  9 months and 12 months

Study Arms (1)

Biofreedom stent

EXPERIMENTAL

Coronary intervention

Device: coronary intervention

Interventions

coronary intervention DEVICE

The BioFreedom drug coated stent (DCS) Coronary Stent Delivery System is comprised of three key components

Biofreedom stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18-85 years old
• Patient indicated for percutaneous coronary intervention with coronary artery disease and without contraindications to implantation of drug eluting stents
• Patient who agrees to have follow-up coronary angiograms

You may not qualify if:

• Patient who refuses to consent to multiple coronary angiograms or coronary angioplasty

Sponsors & Collaborators

• Professor Stephen Lee: lead

Study Sites (1)

Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hospital Authority

Hong Kong, Hong Kong

Location

Related Publications (7)

• Sousa JE, Costa MA, Abizaid AC, Rensing BJ, Abizaid AS, Tanajura LF, Kozuma K, Van Langenhove G, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up. Circulation. 2001 Oct 23;104(17):2007-11. doi: 10.1161/hc4201.098056.

  PMID: 11673337 RESULT

• Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.

  PMID: 16814667 RESULT

• Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26.

  PMID: 14744976 RESULT

• Kornowski R, Hong MK, Tio FO, Bramwell O, Wu H, Leon MB. In-stent restenosis: contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J Am Coll Cardiol. 1998 Jan;31(1):224-30. doi: 10.1016/s0735-1097(97)00450-6.

  PMID: 9426044 RESULT

• Ostojic M, Sagic D, Jung R, Zhang YL, Nedeljkovic M, Mangovski L, Stojkovic S, Debeljacki D, Colic M, Beleslin B, Milosavljevic B, Orlic D, Topic D, Karanovic N, Paunovic D, Christians U; NOBORI PK Investigators. The pharmacokinetics of Biolimus A9 after elution from the Nobori stent in patients with coronary artery disease: the NOBORI PK study. Catheter Cardiovasc Interv. 2008 Dec 1;72(7):901-8. doi: 10.1002/ccd.21775.

  PMID: 19016466 RESULT

• Tada N, Virmani R, Grant G, Bartlett L, Black A, Clavijo C, Christians U, Betts R, Savage D, Su SH, Shulze J, Kar S. Polymer-free biolimus a9-coated stent demonstrates more sustained intimal inhibition, improved healing, and reduced inflammation compared with a polymer-coated sirolimus-eluting cypher stent in a porcine model. Circ Cardiovasc Interv. 2010 Apr;3(2):174-83. doi: 10.1161/CIRCINTERVENTIONS.109.877522.

  PMID: 20407114 RESULT

• Prati F, Cera M, Ramazzotti V, Imola F, Giudice R, Albertucci M. Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios. EuroIntervention. 2007 Nov;3(3):365-70. doi: 10.4244/eijv3i3a66.

  PMID: 19737719 RESULT

MeSH Terms

Conditions

Coronary Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

2 patients had difficult guiding-catheter engagement for optimal baseline OCT imaging with lots of blood-displacement artifacts; obtaining good future OCT assessments were impossible and were excluded from the study (replaced by another 2 patients).

Results Point of Contact

• Title: Prof. Stephen Wai-luen LEE
• Organization: Queen Mary Hospital,University of Hong kong

prof.stephenlee@gmail.com ; kongsl@hku.hk

(852) 22555409 or 28181314

Study Officials

• Stephen WL Lee, MD FRCP FACC

  Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hospital Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 4, 2013
• Study Start: December 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 14, 2017
• Results First Posted: January 18, 2016

Record last verified: 2017-06

Locations

HK (1)