Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT01556126
• Date of registration: 14/03/2012
• Prospective Registration: No
• Primary sponsor: CID - Carbostent & Implantable Devices
• Public title: Clinical Performance of CRE8 Drug Eluting Stent in All Comer Population PARTICIPATE
• Scientific title: Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients
• Date of first enrolment: February 2012
• Target sample size: 1191
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01556126
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Belgium, Italy, Netherlands, Norway, Poland

Contacts

• Name: Antonio Colombo, MD
• Affiliation: Fondazione San Raffaele del Monte Tabor

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stable Angina

Acute Myocardial Infarction

Unstable Angina

Intervention(s)

Device: Amphilimus Eluting Stent (CRE8)

Primary Outcome(s)

Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR [Time Frame: 6 months]

Secondary Outcome(s)

Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup). [Time Frame: At 6 months]

Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization [Time Frame: At 30 days, 1 year and yearly up to 5 years]

Stent thrombosis [Time Frame: within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years]

Secondary ID(s)

C21102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors