Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS

Unstable Angina Clinical Trial

— DEMONSTRATE  

Official title:

Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543373
• Other study ID #: C21101
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2018
• Source: CID - Carbostent & Implantable Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years;

• Patients with symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;

• Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);

• Left ventricular ejection fraction > 30%;

• Patients presenting with at least two vessels disease requiring a staged procedure within 3 months, according to the operator judgement;

• Target de-novo lesion;

• Target lesion located in a target vessel with a diameter ranging from 2.5 to 3.75 mm;

• Target lesion diameter stenosis > 50% and < 100% by visual estimate, with a TIMI flow of >=1;

• Discrete lesion with a length ranging from 13 to 25 mm;

• The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (Cre8 or Vision/Multilink 8), according to the randomization arm;

• Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.

Exclusion Criteria:

• Female with childbearing potential or lactating;

• Patient presenting with acute myocardial infarction with ST elevation;

• Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;

• Cerebrovascular accident within the past 6 months;

• Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);

• Thrombocytopenia (platelet count less than 100,000/mm³);

• Known bleeding or hypercoagulable disorder;

• Currently under immunosuppressant therapy;

• Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;

• Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;

• Patient underwent target vessel revascularization with a DES;

• Heavily calcified vessel and/or lesion which cannot be successfully predilated or imaged by OCT

• Target lesion is located or supplied by an arterial or venous bypass graft;

• Lesion located very distally, difficult to be imaged by OCT;

• Lesion located in angulated (>70°), sharp take-off vessel;

• Target lesion involving a bifurcation with a side branch =2.0 mm in diameter;

• Target lesion located in the left main stem;

• Ostial lesion location;

• Target lesion has TIMI 0 flow;

• Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• NSTEMI
• Stable Angina
• Unstable Angina

Intervention

Device:
• Amphilimus Eluting Stent
Sirolimus formulated coronary eluting stent
• Bare Metal Stent
Bare metal coronary stent

Locations

Country	Name	City	State
Italy	ULSS n°3 - Ospedale Civile	Bassano del Grappa	VI
Italy	Azienda Ospedaliero - Universitaria S.Anna	Ferrara	FE
Italy	Azienda Ospedaliera S. Giovanni - Addolorata	Roma	RM
Italy	Policlinico Universitario "Agostino Gemelli"	Roma	RM
Italy	Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino"	Torino	TO
Netherlands	University Medical Centre Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
CID - Carbostent & Implantable Devices

Countries where clinical trial is conducted

Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of = 0.3, determined by OCT	1 month for the BMS arm; 3 months for the DES arm	within 3 months from index procedure
Secondary	Percentage of malapposed stent struts		Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Secondary	Percentage of malapposed and uncovered stent struts		1 month (BMS arm) / 3 months (DES arm)
Secondary	Neointimal growth and neointimal thickness		1 month (BMS arm) / 3 months (DES arm)
Secondary	Angiographic in-stent and in-segment endpoints	reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss	immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm)
Secondary	Clinical composite endpoints	Cardiac death/Target vessel MI/Clinically indicated TLR; All death/All MI/All TVR (including TLR)	At 1, 3 and 12 months
Secondary	Stent Thrombosis		during index procedure, immediately after index procedure, 1 month, 3 months, 12 months