Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES (DISCOVERY123)

Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent (Development Code TCD-10023) With Biodegradable Polymer at 1, 2 and 3 Months

Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: TCD-10023 drug eluting stent

Detailed Description

We will enroll patients with multiple coronary lesions, which, as is routine practice, will be treated with the new DES in 2 sessions (second one approximately 3-5 weeks after the first one). We will assess lesions by OFDI after the implantation and at the time of 3 months follow-up, when we will ask patients to undergo a coronary angiography. Patients will then have a follow-up contact at 1 year after initial implantation.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Massy, France, 91300
    • Cardiovascular Institute Paris Sud (ICPS)
  • Toulouse, France, 31059
    • CHU Rangueil
• Germany
  • Munchen, Germany, 81377
    • LMU
• Netherlands
  • Leeuwarden, Netherlands, 8934 AD
    • MCL
  • Rotterdam, Netherlands
    • Maasstadziekenhuis
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is at least 18 years old
• Patients is a suitable candidate for Percutaneous Coronary Intervention (PCI)
• Patient has multi-vessel disease with ≥2 de-novo lesions in native coronary arteries suitable for treatment with TCD-10023 DES
• Target lesions are suitable for OFDI examination;
• Patient requires staged procedure between 3-5 weeks after baseline procedure, according to investigator's judgement
• Target vessel reference diameter is between 2.5 - 4.0 mm (visual assessment)
• Patient has provided written informed consent
• Patient is affiliated to social security or equivalent system (France only)

Exclusion Criteria:

• - Patient has known allergy to sirolimus, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated)
• Patient is not a suitable candidate for use of Dual Anti-Platelet Therapy (DAPT) because of active or recent bleedings or for use of vitamin K antagonist, like warfarin, dabigatran, rivaroxaban or acenocoumarol;
• Patient is presenting with ST-segment elevated MI (STEMI) at baseline procedure
• Patient has Killip-class > 1 at admission
• Patient is in cardiogenic shock
• Patient is a female of childbearing potential
• Patient has life expectancy of less then 1 year
• Patient is expected to undergo major surgery within 3 months
• Patient has Left Main disease ≥ 50%
• Target lesion at bifurcation requiring 2 stents technique
• Target lesions are severely calcified
• Target lesion is located within 3 mm of aorta-ostium
• Patient has renal failure defined as estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m²
• Target lesions require preparation other than balloon pre-dilatation
• Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials
• In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
• Patient is under judicial protection (France only)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TCD-10023 drug eluting stent; All patients will be treated with the new Drug eluting stent TCD-10023	Device: TCD-10023 drug eluting stent; Implantation of new drug eluting stent in coronary artery lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
OFDI assessed percent stent strut coverage	3 months post procedure.

Secondary Outcome Measures

Outcome Measure	Time Frame
% stent strut coverage	at 1 and 2 months
% stented lesions with >10% uncovered struts	at 1, 2, 3 months
% of stented lesions with >20% uncovered stent struts	at 1, 2, 3 months
% of acquired mal-apposed stent struts	at 1, 2, 3 months
amount (mm³) of in-stent intimal hyperplasia	at 1, 2, 3 months
amount (mm³)of in-segment hyperplasia	at 1, 2, 3 months
neo-intimal thickness (µm)	at 1, 2, 3 months
in-stent late lumen loss (mm) assessed by Quantitative Coronary Angiography (QCA)	at 3 months
In-segment late lumen loss (mm) assessed by QCA	at 3 months
Target Lesion revascularization (TLR)	at 1, 3, 12 months
Target Lesion Failure (TLF - composite of cardiac death, Myocardial infarction, TLR	at 1, 3, 12 months
Target Vessel Revascularization (TVR)	at 1, 3, 12 months
Major Cardiac Adverse Events (MACE) defined as cardiac death, Q wave and non-Q wave Myocardial Infarction (MI) , emergent coronary artery bypass surgery, or target vessel revascularization (TVR)	at 1, 3, 12 months
Stent thrombosis	at 1, 3 and 12 months

Collaborators and Investigators

• Sponsor: Terumo Europe N.V.
• Investigators: Study Chair: Pieter Smits, MD, Maasstad hospital, Rotterdam, the Netherlands; Study Chair: Bernard Chevalier, MD, Cardiovascular Institute Paris Sud, Massy, France

Publications and helpful links

General Publications

• Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (ESTIMATE): May 1, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; coronary artery disease; Drug eluting stents; Tomography, Optical Coherence
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: T121E4