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

Coronary Artery Disease Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844843
• Other study ID #: T121E4
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2019
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• TCD-10023 drug eluting stent
Implantation of new drug eluting stent in coronary artery lesions

Locations

Country	Name	City	State
France	Cardiovascular Institute Paris Sud (ICPS)	Massy
France	CHU Rangueil	Toulouse
Germany	LMU	Munchen
Netherlands	MCL	Leeuwarden
Netherlands	Erasmus	Rotterdam
Netherlands	Maasstadziekenhuis	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

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