Brief Summary

The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting Stent, in patients comparable to the everyday's clinical practice population, with a specific focus on diabetics, that will be part of a pre-specified study subgroup.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,191

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach

6 countries

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Start

First participant enrolled

February 1, 2012

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed

Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

March 14, 2012

Last Update Submit

July 14, 2021

Conditions

Stable Angina Unstable Angina Acute Myocardial Infarction

Keywords

Coronary artery diseaseDrug Eluting StentAll comers patients

Outcome Measures

Primary Outcomes (1)

Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
6 months

Secondary Outcomes (3)

Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization
At 30 days, 1 year and yearly up to 5 years
Stent thrombosis
within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years
Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup).
At 6 months

Study Arms (1)

Amphilimus eluting stent (Cre8)

EXPERIMENTAL

Sirolimus formulated coronary eluting stent

Device: Amphilimus Eluting Stent (CRE8)

Interventions

Amphilimus Eluting Stent (CRE8)DEVICE

Sirolimus formulated coronary eluting stent

Also known as: CRE8

Amphilimus eluting stent (Cre8)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age \> 18 years;
Patients with symptoms of stable angina or documented silent ischemia;
Patient with coronary artery disease ranging between 0 and 22 according to the Syntax score;
Patients with acute coronary syndrome, including unstable angina, NSTEMI and STEMI;
Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
Left ventricular ejection fraction \> 30%;
Target de-novo lesions with diameter stenosis \> 50% (including total occlusion);
Target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm;
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.

You may not qualify if:

Female with childbearing potential or lactating;
Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
Acute or chronic renal dysfunction (defined as creatinine greater than 2.5 mg/dl or on dialysis);
Thrombocytopenia (platelet count less than 100,000/mm³) or hypercoagulable disorder;
Known significant gastro-intestinal or urinary bleeding within the past 6 months;
Patient refusing blood transfusion;
Patient currently under immunosuppressant therapy;
Patient with planned surgery within 6 months from the index procedure unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
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 within 3 months prior to the index procedure;
Target lesion is located or supplied by an arterial or venous bypass graft.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

CID - Carbostent & Implantable Deviceslead

Study Sites (23)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Azienda USL 8 Arezzo - Ospedale San Donato

Arezzo, AR, 52100, Italy

Location

A.S.L. CN1 - Ospedale SS Annunziata di Savigliano

Savigliano, CN, 12038, Italy

Location

Istituto Clinico Città Studi

Milan, MI, 20131, Italy

Location

Fondazione San Raffaele del Monte Tabor

Milan, MI, 20132, Italy

Location

Centro Cardiologico Monzino

Milan, MI, 20138, Italy

Location

Istituto Clinico Humanitas IRCCS

Rozzano, MI, 20089, Italy

Location

Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli"

Palermo, PA, 90127, Italy

Location

Azienda Ospedaliera di Padova

Padua, PD, 35128, Italy

Location

Azienda Ospedaliera S. Salvatore

Pesaro, PU, 61100, Italy

Location

Azienda Policlinico Umberto I

Roma, RM, 00161, Italy

Location

Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo

Savona, SV, 17100, Italy

Location

ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco

Torino, TO, 10154, Italy

Location

Clinica Mediterranea SpA

Napoli, 80122, Italy

Location

Azienda Ospedaliera Universitaria "Federico II"

Napoli, 80131, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435CM, Netherlands

Location

TweeSteden Ziekenhuis

Tilburg, 5042 AD, Netherlands

Location

Oslo University Hospital - Rikshospitalet

Oslo, 0027, Norway

Location

Klinika Kardiologii SPSK4 w Lublinie

Lublin, 20-954, Poland

Location

Szpital Kliniczny Przemienienia Panskiego

Poznan, 61-848, Poland

Location

MeSH Terms

Conditions

Angina, StableAngina, UnstableCoronary Artery Disease

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

Antonio Colombo, MD
Fondazione San Raffaele del Monte Tabor
PRINCIPAL INVESTIGATOR

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

March 14, 2012

First Posted

March 16, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2018

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

NL(4)AU(1)PL(2)NO(1)BE(1)IT(14)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Amphilimus eluting stent (Cre8)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (23)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations