Status:
COMPLETED
Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES
Lead Sponsor:
Terumo Europe N.V.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- \- 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)
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01844843
Start Date
January 1 2014
End Date
June 1 2016
Last Update
October 8 2019
Active Locations (6)
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1
Cardiovascular Institute Paris Sud (ICPS)
Massy, France, 91300
2
CHU Rangueil
Toulouse, France, 31059
3
LMU
München, Germany, 81377
4
MCL
Leeuwarden, Netherlands, 8934 ad