This trial is active, not recruiting.

Condition coronary artery disease
Treatment tcd-10023 drug eluting stent
Phase phase 3
Sponsor Terumo Europe N.V.
Start date January 2014
End date September 2016
Trial size 60 participants
Trial identifier NCT01844843, T121E4


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
All patients will be treated with the new Drug eluting stent TCD-10023
tcd-10023 drug eluting stent
Implantation of new drug eluting stent in coronary artery lesions

Primary Outcomes

OFDI assessed percent stent strut coverage
time frame: 3 months post procedure.

Secondary Outcomes

% stent strut coverage
time frame: at 1 and 2 months
% stented lesions with >10% uncovered struts
time frame: at 1, 2, 3 months
% of stented lesions with >20% uncovered stent struts
time frame: at 1, 2, 3 months
% of acquired mal-apposed stent struts
time frame: at 1, 2, 3 months
amount (mm³) of in-stent intimal hyperplasia
time frame: at 1, 2, 3 months
amount (mm³)of in-segment hyperplasia
time frame: at 1, 2, 3 months
neo-intimal thickness (µm)
time frame: at 1, 2, 3 months
in-stent late lumen loss (mm) assessed by Quantitative Coronary Angiography (QCA)
time frame: at 3 months
In-segment late lumen loss (mm) assessed by QCA
time frame: at 3 months
Target Lesion revascularization (TLR)
time frame: at 1, 3, 12 months
Target Lesion Failure (TLF - composite of cardiac death, Myocardial infarction, TLR
time frame: at 1, 3, 12 months
Target Vessel Revascularization (TVR)
time frame: 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)
time frame: at 1, 3, 12 months
Stent thrombosis
time frame: at 1, 3 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Terumo Europe N.V..