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

Sponsor

Terumo Europe N.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT01844843

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: TCD-10023 drug eluting stent	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

OFDI assessed percent stent strut coverage [3 months post procedure.]

Secondary Outcome Measures

% 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cardiovascular Institute Paris Sud (ICPS)	Massy	France	91300
2	CHU Rangueil	Toulouse	France	31059
3	LMU	Munchen	Germany	81377
4	MCL	Leeuwarden	Netherlands	8934 ad
5	Erasmus	Rotterdam	Netherlands	3015 CE
6	Maasstadziekenhuis	Rotterdam	Netherlands

Sponsors and Collaborators

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