A Study Comparing Two Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION Study

Coronary Artery Disease Clinical Trial

— OCT-ORION  

Official title:

A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742507
• Other study ID #: UW 12-093
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2012
• Last updated: July 24, 2017
• Start date: April 2012
• Est. completion date: August 2016

Study information

• Verified date: July 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stent coverage and neo-intimal growth can be evaluated in-detail by intracoronary optical coherence tomography (OCT), which is a catheter-based imaging technique. It is performed as part of the PCI procedure. OCT is the optical analogue of intravascular ultrasound (IVUS), except that it can provide much higher resolution of coronary cross sectional images than IVUS. The LightLab C7XR OCT system (Frequency Domain OCT) used in this Hospital has obtained full CE Mark, approved by the US FDA, and approved for clinical use in Hong Kong. It has been shown to be safe in clinical settings and has been used in over 300 patients without complication at Queen Mary Hospital.

In this study, stent coverage and neo-intimal growth between zotarolimus-eluting stents (ZES) and biolimus-eluting stents (BES) will be compared by using OCT at 9 month and specific post-intervention re-study intervals.

The investigators objective is to investigate the clinical impact and OCT difference on early stent healing and late lumen loss between the two new-generation limus-eluting-stents - Resolute Integrity and Biomatrix, which differ in stent design, eluting drug and coating polymer.

Description:

This is a prospective, randomised, assessor-blinded, single centre study. Patients with symptomatic coronary artery diseases in 2 or 3 coronary vessels requiring PCI are eligible for the study. PCI will be performed in the usual manner to all the study lesions in the same procedure. In a randomized fashion, each patient will have one artery with critical disease(s) treated by the Resolute Integrity Stent(s) and the other artery treated by the Biomatrix Stent(s).

Baseline OCT data will be obtained right after stenting. The remaining coronary artery, if diseased and required PCI treatment, will be treated during the angiographic and OCT follow-up as a staged procedure. Patients will be randomly assigned into 5 groups with equal number, receiving a follow-up coronary angiogram with OCT from 2, 3, 4, 5 and 6 months interval post-intervention. Each patient will serve as his/her own control comparing the 2 types of stents. At 9-month post-intervention, all patients will receive a second follow-up coronary angiogram with OCT. All OCT data analyses will be performed in a blinded fashion by a core laboratory. Phone follow up will be carried out for cardiac events at 1 year and 2 year of post intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient aged 18-85 years old

• Patient with symptomatic coronary artery diseases involving two or more vessels requiring percutaneous coronary intervention

Exclusion Criteria:

• Patient who is unable to give consent

• Patient in acute myocardial infarction or unstable angina

• Patient who is hemodynamically unstable

• Patient who is allergic to contrast agents

• Patient who is allergic to anti-platelet agents

• Patient who is allergic to zotarolimus

• Patient who is allergic to biolimus

• Patient who is pregnant

• Patient who has planned surgery in the following 12 months after percutaneous coronary intervention

• Left main coronary lesion

• Bifurcation lesion

• Chronic total occlusion lesion

• Coronary vessel size smaller than 2.5mm

• Coronary lesion longer than 38mm in length

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Integrity Stent
Resolute Integrity Stent
• Biomatrix stent
Biomatrix stent

Locations

Country	Name	City	State
Hong Kong	Division of Cardiology, Department of Medicine, QMH	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (17)

Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Jüni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting — View Citation

Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. — View Citation

Grube E, Buellesfeld L. BioMatrix Biolimus A9-eluting coronary stent: a next-generation drug-eluting stent for coronary artery disease. Expert Rev Med Devices. 2006 Nov;3(6):731-41. Review. — View Citation

Grube E, Hauptmann KE, Buellesfeld L, Lim V, Abizaid A. Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9 eluting stent with a biodegradable polymer coating. EuroIntervention. 2005 May;1(1):53-7. — View Citation

Kastrati A, Mehilli J, Pache J, Kaiser C, Valgimigli M, Kelbaek H, Menichelli M, Sabaté M, Suttorp MJ, Baumgart D, Seyfarth M, Pfisterer ME, Schömig A. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar — View Citation

Kim JS, Fan C, Choi D, Jang IK, Lee JM, Kim TH, Park SM, Paik SI, Ko YG, Hong MK, Jang Y, Chung N. Different patterns of neointimal coverage between acute coronary syndrome and stable angina after various types of drug-eluting stents implantation; 9-month — View Citation

Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. — View Citation

Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of — View Citation

Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native co — View Citation

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. EuroInterve — View Citation

Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita — View Citation

Silber S, Windecker S, Vranckx P, Serruys PW; RESOLUTE All Comers investigators. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lance — View Citation

Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 20 — View Citation

Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007 Mar — View Citation

Udipi K, Melder RJ, Chen M, Cheng P, Hezi-Yamit A, Sullivan C, Wong J, Wilcox J. The next generation Endeavor Resolute Stent: role of the BioLinx Polymer System. EuroIntervention. 2007 May;3(1):137-9. — View Citation

Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable — View Citation

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 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• OCT derived percentage stent strut coverage at 9 month	OCT derived percentage stent strut coverage at 9 month	9 month
Secondary	Angiographic binary stenosis	• Angiographic binary stenosis at 9 month	9 month
Secondary	• OCT derived neo-intimal area at 9 month	• OCT derived neo-intimal area at 9 month	at 9 month
Secondary	• Minimal lumen diameter by Quantitative Coronary Analysis (QCA) at 9 month	• Minimal lumen diameter by Quantitative Coronary Analysis (QCA) at 9 month	9 month
Secondary	• All major adverse cardiac events (all cardiac deaths, myocardial infarction, target vessel failure and target lesion revascularization, and stent thrombosis) at the pre-defined 2 to 9 months angiographic and OCT follow-up.	• All major adverse cardiac events (all cardiac deaths, myocardial infarction, target vessel failure and target lesion revascularization, and stent thrombosis) at the pre-defined 2 to 9 months angiographic and OCT follow-up.	2 to 9 months
Secondary	• Target vessel stent thrombosis per Academic Research Consortium (ARC) definition	• Target vessel stent thrombosis per Academic Research Consortium (ARC) definition	from enrollment till 2 years follow up
Secondary	Percentage of stent strut malapposition	Percentage of stent strut malapposition	9 month
Secondary	Mean neo-intimal thickness (NIT) at 9 month	Mean neo-intimal thickness (NIT) at 9 month	9 month
Secondary	Stent volume	Stent volume	at 9 month
Secondary	Lumen volume	Lumen volume	at 9 month
Secondary	Neointimal Hyperplasia (NIH) volume	Neointimal Hyperplasia (NIH) volume	at 9 month