STACCATO: Stent sTrut Apposition and Coverage in Coronary ArTeries: an Optical Coherence Tomography (OCT) Study

NCT01065519 | Completed

• 1 other identifier: EudraCT 2009-010923-14
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of vessel healing after DES implantation in STEMI, NSTEMI and stable/unstable angina patients: a randomized comparison between everolimus and biolimus A9-eluting stents: an optical coherence tomography (OCT) and intravascular ultrasound-tissue characterisation (IVUS-TC) study. Plaque characterisation substudy: Assessment of culprit lesions in different subsets of patients (STEMI, NSTEMI and stable/unstable angina) by use of optical coherence tomography (OCT) and intravascular ultrasound tissue characterisation (IVUS-TC).

Conditions

Coronary Artery Disease

Keywords

Coronary stent; Optical coherence tomography; Intravascular ultrasound

Outcome Measures

Primary Outcomes (1)

• Stent strut coverage and stent strut apposition, assessed with OCT

  9 months

Secondary Outcomes (1)

• Lumen Loss (in-stent) at 9 months In-segment Late Lumen Loss at 9 months Cumulative MACE rate at 9 months Stent thrombosis at all follow-ups Target lesion revascularisation Device succes

  9 months, 12 months, yearly until 5 years

Study Arms (2)

1

ACTIVE COMPARATOR

drug-eluting stent

Device: Xience V everolimus eluting stent

2

ACTIVE COMPARATOR

Biolimus A9-eluting Biomatrix stent

Device: Biolimus A9-eluting Biomatrix stent

Interventions

Xience V everolimus eluting stent DEVICE

Xience V everolimus eluting stent

1

Biolimus A9-eluting Biomatrix stent DEVICE

Biolimus A9-eluting Biomatrix stent

2

Eligibility Criteria

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

You may qualify if:

• Patient older than 18 years
• Written informed consent available
• Patient eligible for percutaneous coronary intervention
• patients with a single or multiple de novo lesion(s) from 3 different patient subsets (STEMI, NSTEMI, stable/unstable angina). Target reference vessel diameter measured by QCA: 2-4 mm

You may not qualify if:

• Left ventricular ejection fraction of \< 30%
• Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support)
• Impaired renal function (serum creatinine \> 2.0 mg/dl)
• Target lesion located in bifurcation
• Lesion of the left main trunk \> 50%, unprotected
• Known allergies to antiplatelet, anticoagulation therapy, contrast media, everolimus or biolimus A9
• Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
• Patients with a life expectancy of less than one year
• Patient currently enrolled in other investigational device or drug trial
• Patient not able or willing to adhere to follow-up visits

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: June 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: January 14, 2016
• Last Updated: January 31, 2023

Record last verified: 2009-04

Locations

BE (1)