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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01844843
First Posted: May 1, 2013
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Terumo Europe N.V.
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Device: TCD-10023 drug eluting stent Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:
  • OFDI assessed percent stent strut coverage [ Time Frame: 3 months post procedure. ]

Secondary Outcome Measures:
  • % 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 ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TCD-10023 drug eluting stent
All patients will be treated with the new Drug eluting stent TCD-10023
Device: TCD-10023 drug eluting stent
Implantation of new drug eluting stent in coronary artery lesions

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844843


Locations
France
Cardiovascular Institute Paris Sud (ICPS)
Massy, France, 91300
CHU Rangueil
Toulouse, France, 31059
Germany
LMU
Munchen, Germany, 81377
Netherlands
MCL
Leeuwarden, Netherlands, 8934 ad
Erasmus
Rotterdam, Netherlands, 3015 CE
Maasstadziekenhuis
Rotterdam, Netherlands
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
Study Chair: Pieter Smits, MD Maasstad Hospital, Rotterdam, The Netherlands
Study Chair: Bernard Chevalier, MD Cardiovascular Institute Paris Sud, Massy, France
  More Information

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01844843     History of Changes
Other Study ID Numbers: T121E4
First Submitted: April 29, 2013
First Posted: May 1, 2013
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by Terumo Europe N.V.:
Drug eluting stents
coronary artery disease
Percutaneous Coronary Intervention
Tomography, Optical Coherence

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases