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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % 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 ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844843

Contacts
Contact: Danny Detiege, SRN +32472808182 danny.detiege@terumo-europe.com
Contact: Virginie de Hemptinne, PhD +32470994700 virginie.dehemptinne@terumo-europe.com

Locations
France
Cardiovascular Institute Paris Sud (ICPS) Recruiting
Massy, France, 91300
Contact: Bernard Chevalier, MD    +33160134602    b.chevalier@icps.com.fr   
CHU Rangueil Recruiting
Toulouse, France, 31059
Contact: Didier Carrie, Prof    +33561323311    carrie.didier@chu-toulouse.fr   
Contact: Jacqueline Cahuzac, SRN    +33561323345    cahuzac.j@chu-toulouse.fr   
Germany
LMU Recruiting
Munchen, Germany, 81377
Principal Investigator: julinda mehilli         
Netherlands
MCL Not yet recruiting
Leeuwarden, Netherlands, 8934 ad
Principal Investigator: Ad van Boven         
Erasmus Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Principal Investigator: Evelyn Regar         
Maasstadziekenhuis Recruiting
Rotterdam, Netherlands
Contact: Pieter Smits, MD    +31102913278    smitsp@maasstadziekenhuis.nl   
Contact: Ria Van Vliet    +31102913278    vlietM@maasstadziekenhuis.nl   
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

No publications provided

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01844843     History of Changes
Other Study ID Numbers: T121E4
Study First Received: April 29, 2013
Last Updated: May 5, 2014
Health Authority: Netherlands: Dutch Health Care Inspectorate
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on July 20, 2014