OCT Evaluation of Healing of COMBO Stent

NCT01274234 | Completed Phase 1 DMC

• 1 other identifier: UW 10-342 (IRB HKU)
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

All subjects requiring percutaneous coronary intervention (PCI) and stenting are eligible to participate in the study. Restudy coronary angiogram with Optical Coherence Tomography (OCT) would be performed between 1 to 5 months at the time of a staged PCI procedure (for remaining coronary disease) or as clinically indicated, and then at 9 months. At the time of the 9-month restudy (a proper time window for drug eluting stent to develop into restenosis should it occur), any new disease detected or restenosis will be treated. The reported incidence of drug eluting stent restenosis is around 10% in simple lesions and is expected to be higher in diabetic patients, long lesions and multi-vessel diseases; a restudy at 9 months actually confers better protection to the patients with advanced disease and any restenosis can be treated timely. All data on clinical events and progress will be monitored and regular follow-ups will be carried out.

Conditions

Coronary Restenosis; Coronary Thrombosis

Keywords

EPC capturing sirolimus eluting COMBO stent; Optical coherence tomography (OCT); Early neointimal healing and stent coverage; Late neointimal thickness, neointimal area, and lumen loss

Outcome Measures

Primary Outcomes (1)

• Primary end-point: OCT findings on percentage stent strut coverage in the 2nd to the 5th months (4 monthly groups).

  Primary end-point: OCT findings on percentage stent strut coverage, malapposition, and neointimal thickness in the 2nd to the 5th months (4 monthly groups).

  On 2nd, 3rd, 4th, and 5th months

Secondary Outcomes (6)

• OCT findings on late loss (neointimal thickness and neointimal area) at 9 months restudy.

  9 months

• Major Adverse Cardiac Events

  Initial OCT follow up, 9 months follow up and one year follow up

• Major Adverse Cardiac Events

  Initial OCT follow up, 9 months OCT follow up and one year follow up

• Any Stent Thrombosis according the Academic Research Consortium

  Initial OCT follow up, 9 months OCT follow up and one year follow up

• Stroke

  Initial OCT follow up, 9 months OCT follow up and one year follow up

Study Arms (1)

COMBO Stent

EXPERIMENTAL

COMBO Stent

Device: COMBO Stent (OrbusNeich Medical, Fort Lauderdale, Florida)

Interventions

COMBO Stent (OrbusNeich Medical, Fort Lauderdale, Florida) DEVICE

The COMBO Stent is a hybrid version of the GENOUS Stent. Upon implantation to the coronary artery, the stent will deliver a drug (sirolimus) to the wall of the treated segment to suppress neointimal growth, in addition to the anti-CD34 antibody coating which will in theory attract circulatory endothelial progenitor cells to hasten endothelialization and promote healing of the stented segment, and thereby may reduce late stent thrombosis.

Also known as: COMBO Stent

COMBO 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 with coronary stenosis requiring percutaneous coronary intervention without contraindications to implantation of drug eluting stents
• patient who consents to receive follow-up coronary angiogram and OCT examination.

You may not qualify if:

• \- patient who refuses to consent to follow-up coronary angiogram or OCT examination.

Sponsors & Collaborators

• Prof. Stephen Lee: lead

Study Sites (1)

Division of Cardiology, Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (7)

• Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005 May 17;45(10):1574-9. doi: 10.1016/j.jacc.2005.01.048.

  PMID: 15893169 RESULT

• Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-term clinical follow-up. Am Heart J. 2008 Jan;155(1):128-32. doi: 10.1016/j.ahj.2007.08.031. Epub 2007 Nov 26.

  PMID: 18082503 RESULT

• Miglionico M, Patti G, D'Ambrosio A, Di Sciascio G. Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: a prospective single-center registry in high-risk patients. Catheter Cardiovasc Interv. 2008 Apr 1;71(5):600-4. doi: 10.1002/ccd.21437.

  PMID: 18360849 RESULT

• Granada JF, Inami S, Aboodi MS, Tellez A, Milewski K, Wallace-Bradley D, Parker S, Rowland S, Nakazawa G, Vorpahl M, Kolodgie FD, Kaluza GL, Leon MB, Virmani R. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ Cardiovasc Interv. 2010 Jun 1;3(3):257-66. doi: 10.1161/CIRCINTERVENTIONS.109.919936. Epub 2010 May 4.

  PMID: 20442358 RESULT

• Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.

  PMID: 18307999 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

• Lee SW, Lam SC, Tam FC, Chan KK, Shea CP, Kong SL, Wong AY, Yung A, Zhang LW, Tse HF, Wu KK, Chan R, Haude M, Mehran R, Mintz GS, Maehara A. Evaluation of Early Healing Profile and Neointimal Transformation Over 24 Months Using Longitudinal Sequential Optical Coherence Tomography Assessments and 3-Year Clinical Results of the New Dual-Therapy Endothelial Progenitor Cell Capturing Sirolimus-Eluting Combo Stent: The EGO-Combo Study. Circ Cardiovasc Interv. 2016 Jul;9(7):e003469. doi: 10.1161/CIRCINTERVENTIONS.115.003469.

  PMID: 27418609 DERIVED

MeSH Terms

Conditions

Coronary Restenosis; Coronary Thrombosis

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Thrombosis; Embolism and Thrombosis

Study Officials

• Stephen Lee, MD FRCP FACC

  Queen Mary Hospital, The Unversity of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: January 11, 2011
• Study Start: October 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

HK (1)