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

NCT01844843 | Completed DMC

• 1 other identifier: T121E4
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 6

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 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.

Conditions

Coronary Artery Disease

Keywords

Drug eluting stents; coronary artery disease; Percutaneous Coronary Intervention; Tomography, Optical Coherence

Outcome Measures

Primary Outcomes (1)

• OFDI assessed percent stent strut coverage

  3 months post procedure.

Secondary Outcomes (14)

• % stent strut coverage

  at 1 and 2 months

• % stented lesions with >10% uncovered struts

  at 1, 2, 3 months

• % of stented lesions with >20% uncovered stent struts

  at 1, 2, 3 months

• % of acquired mal-apposed stent struts

  at 1, 2, 3 months

• amount (mm³) of in-stent intimal hyperplasia

  at 1, 2, 3 months

Study Arms (1)

TCD-10023 drug eluting stent

EXPERIMENTAL

All patients will be treated with the new Drug eluting stent TCD-10023

Device: TCD-10023 drug eluting stent

Interventions

TCD-10023 drug eluting stent DEVICE

Implantation of new drug eluting stent in coronary artery lesions

TCD-10023 drug eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (6)

Cardiovascular Institute Paris Sud (ICPS)

Massy, 91300, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

LMU

München, 81377, Germany

Location

MCL

Leeuwarden, 8934 ad, Netherlands

Location

Erasmus

Rotterdam, 3015 CE, Netherlands

Location

Maasstadziekenhuis

Rotterdam, Netherlands

Location

Related Publications (1)

• Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.

  PMID: 29246909 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Pieter Smits, MD

  Maasstad hospital, Rotterdam, the Netherlands

  STUDY CHAIR

• Bernard Chevalier, MD

  Cardiovascular Institute Paris Sud, Massy, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

FR (2); NL (3); DE (1)