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

Terumo

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: TCD-10023 drug eluting stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01844843

T121E4

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)