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

January 27, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

Assessment of Vessel Healing After DES Implantation With STEMI, NSTEMI and Stable/Unstable Angina Patients: a Randomized Study Between Everolimus and Biolimus A9-eluting Stents: an Optical Coherence Tomography (OCT) and Intravascular Ultrasound Tissue Characterisation (IVUS-TC) Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. The use of DES in STEMI and NSTEMI is still a matter of intense debate. Reassuring data of trials, meta-analyses and registries conflict with reports of delayed arterial healing and higher risk of stent thrombosis after DES implantation in ACS patients. Heterogeneity in healing (bad healing at the site of the necrotic core), stent strut malapposition and plaque prolapse are all proposed as possible causes for a higher risk of stent thrombosis. Furthermore, next generation DES claims a better safety profile in comparison to first-generation DES.
  2. Thus far, our information on tissue characterisation of coronary plaques prone to rupture, relies on histopathology data. Recently, new invasive coronary imaging techniques; radiofrequency intravascular ultrasound (RF-IVUS) and optical coherence tomography (OCT) provide new possibilities for in vivo assessment of coronary plaques.

Aims:

  1. To evaluate vessel healing, expressed as stent strut coverage and stent strut apposition assessed with OCT at 9 months after PCI and compare between everolimus Xience V (Abbott Vascular, Santa Clara, CA) and biolimus A9-eluting Biomatrix (Biosensors, Newport Beach, CA) stents, in 3 different groups of patient subsets (STEMI, NSTEMI and patients with stable/unstable angina).
  2. To make, by use of OCT and IVUS-TC, a detailed characterisation of coronary lesions before PCI and to study the possible link between specific lesion characteristics (e.g. thin cap fibroatheroma, large necrotic core, extensive calcification,…) and outcome (risk of distal embolisation and myonecrosis in the short term, risk of bad strut coverage or risk of restenosis or stent thrombosis on longer term). To compare the performance of both technologies (OCT and IVUS-TC) in a direct way.
  3. To assess, by use of OCT and IVUS-TC, the stented segment just after the intervention (assessment of stent expansion, stent strut apposition, detection of edge dissection, intraluminal thrombus) and correlate with angiographic and clinical outcomes. Again, the performance of both technologies will be compared in a direct way.
  4. To study the influence of drug-eluting stent implantation in a 3-5 cm long segment of the coronary artery just distal to the implanted stent by use of OCT at baseline and at 9 months after stent implantation.

Methods: Patients undergoing PCI are recruited from 3 groups of patients: patients with STEMI (group I), patients with NSTEMI (group II) and patients with stable/unstable angina (group III). From each group, 20 patients are included. In each individual group, randomization between an everolimus-eluting stent and a biolimus A9-eluting stent is performed. All patients undergo IVUS-TC and OCT examination of the stented segment (and the 3 to 5 cm distal from the stented segment) just before and after stent implantation at the time of the index procedure. All patients undergo control angiography with OCT examination at 9 months follow-up.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient older than 18 years
  2. Written informed consent available
  3. Patient eligible for percutaneous coronary intervention
  4. 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
drug-eluting stent
Device: Xience V everolimus eluting stent
Xience V everolimus eluting stent
Active Comparator: 2
Biolimus A9-eluting Biomatrix stent
Device: Biolimus A9-eluting Biomatrix stent
Biolimus A9-eluting Biomatrix stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stent strut coverage and stent strut apposition, assessed with OCT
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 9 months, 12 months, yearly until 5 years
9 months, 12 months, yearly until 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

January 14, 2016

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2009-010923-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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