Clinical trial NCT01844843: Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug eluting stents
coronary artery disease
Percutaneous Coronary Intervention
Tomography, Optical Coherence
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: OFDI assessed percent stent strut coverage
timeFrame: 3 months post procedure.
Secondary outcomes:
measure: % stent strut coverage
timeFrame: at 1 and 2 months
measure: % stented lesions with >10% uncovered struts
timeFrame: at 1, 2, 3 months
measure: % of stented lesions with >20% uncovered stent struts
timeFrame: at 1, 2, 3 months
measure: % of acquired mal-apposed stent struts
timeFrame: at 1, 2, 3 months
measure: amount (mm³) of in-stent intimal hyperplasia
timeFrame: at 1, 2, 3 months
measure: amount (mm³)of in-segment hyperplasia
timeFrame: at 1, 2, 3 months
measure: neo-intimal thickness (µm)
timeFrame: at 1, 2, 3 months
measure: in-stent late lumen loss (mm) assessed by Quantitative Coronary Angiography (QCA)
timeFrame: at 3 months
measure: In-segment late lumen loss (mm) assessed by QCA
timeFrame: at 3 months
measure: Target Lesion revascularization (TLR)
timeFrame: at 1, 3, 12 months
measure: Target Lesion Failure (TLF - composite of cardiac death, Myocardial infarction, TLR
timeFrame: at 1, 3, 12 months
measure: Target Vessel Revascularization (TVR)
timeFrame: at 1, 3, 12 months
measure: 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)
timeFrame: at 1, 3, 12 months
measure: Stent thrombosis
timeFrame: at 1, 3 and 12 months
Other outcomes:
Locations:
city: Massy
country: France
facility: Cardiovascular Institute Paris Sud (ICPS)
city: Toulouse
country: France
facility: CHU Rangueil
city: Munchen
country: Germany
facility: LMU
city: Leeuwarden
country: Netherlands
facility: MCL
city: Rotterdam
country: Netherlands
facility: Erasmus
city: Rotterdam
country: Netherlands
facility: Maasstadziekenhuis
Study officials:
affiliation: Maasstad hospital, Rotterdam, the Netherlands
name: Pieter Smits, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Institute Paris Sud, Massy, France
name: Bernard Chevalier, MD
role: STUDY_CHAIR
References:
citation: 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.