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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Terumo Europe N.V.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01844843
First received: April 29, 2013
Last updated: May 5, 2014
Last verified: May 2014

April 29, 2013
May 5, 2014
January 2014
June 2015   (final data collection date for primary outcome measure)
OFDI assessed percent stent strut coverage [ Time Frame: 3 months post procedure. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01844843 on ClinicalTrials.gov Archive Site
  • % stent strut coverage [ Time Frame: at 1 and 2 months ] [ Designated as safety issue: No ]
  • % stented lesions with >10% uncovered struts [ Time Frame: at 1, 2, 3 months ] [ Designated as safety issue: No ]
  • % of stented lesions with >20% uncovered stent struts [ Time Frame: at 1, 2, 3 months ] [ Designated as safety issue: No ]
  • % of acquired mal-apposed stent struts [ Time Frame: at 1, 2, 3 months ] [ Designated as safety issue: No ]
  • amount (mm³) of in-stent intimal hyperplasia [ Time Frame: at 1, 2, 3 months ] [ Designated as safety issue: No ]
  • amount (mm³)of in-segment hyperplasia [ Time Frame: at 1, 2, 3 months ] [ Designated as safety issue: No ]
  • neo-intimal thickness (µm) [ Time Frame: at 1, 2, 3 months ] [ Designated as safety issue: No ]
  • in-stent late lumen loss (mm) assessed by Quantitative Coronary Angiography (QCA) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • In-segment late lumen loss (mm) assessed by QCA [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • Target Lesion revascularization (TLR) [ Time Frame: at 1, 3, 12 months ] [ Designated as safety issue: Yes ]
  • Target Lesion Failure (TLF - composite of cardiac death, Myocardial infarction, TLR [ Time Frame: at 1, 3, 12 months ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: at 1, 3, 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: at 1, 3 and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: TCD-10023 drug eluting stent
Implantation of new drug eluting stent in coronary artery lesions
Experimental: TCD-10023 drug eluting stent
All patients will be treated with the new Drug eluting stent TCD-10023
Intervention: Device: TCD-10023 drug eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2016
June 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Danny Detiege, SRN +32472808182 danny.detiege@terumo-europe.com
Contact: Virginie de Hemptinne, PhD +32470994700 virginie.dehemptinne@terumo-europe.com
France,   Germany,   Netherlands
 
NCT01844843
T121E4
Yes
Terumo Europe N.V.
Terumo Europe N.V.
Not Provided
Study Chair: Pieter Smits, MD Maasstad Hospital, Rotterdam, The Netherlands
Study Chair: Bernard Chevalier, MD Cardiovascular Institute Paris Sud, Massy, France
Terumo Europe N.V.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP