Coronary Artery DiseaseSTACCATONCT01065519
STACCATO: Stent sTrut Apposition and Coverage in Coronary ArTeries: an Optical Coherence Tomography (OCT) Study
A study testing Xience V everolimus eluting stent and Biolimus A9-eluting Biomatrix stent in people with Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Xience V everolimus eluting stent and Biolimus A9-eluting Biomatrix stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2009to 14 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the detailed description
- 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.
- 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:
- 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).
- 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.
- 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.
- 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Xience V everolimus eluting stent, Biolimus A9-eluting Biomatrix stent
- Keywords
- Coronary stent, Optical coherence tomography, Intravascular ultrasound
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xience V everolimus eluting stentDevice
Xience V everolimus eluting stent
Biolimus A9-eluting Biomatrix stentDevice
Biolimus A9-eluting Biomatrix stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | drug-eluting stent Receives: Device: Xience V everolimus eluting stent |
| 2 | Active comparator | Biolimus A9-eluting Biomatrix stent Receives: Device: Biolimus A9-eluting Biomatrix stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent strut coverage and stent strut apposition, assessed with OCT
Measured: 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
Measured: 9 months, 12 months, yearly until 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJun 2009
- Primary completionFeb 2011
- Study completion14 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065519
- Sponsor's protocol ID
- EudraCT 2009-010923-14
- Acronym
- STACCATO
- Status last verified
- Apr 2009
- First submitted
- 8 Feb 2010
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01065519
- Acronym / sponsor ID
- STACCATO / EudraCT 2009-010923-14
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary stent, Optical coherence tomography, Intravascular ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- 14 Jan 2016 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- 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.
- 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:
- 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).
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Xience V everolimus eluting stentdrug-eluting stent |
| 2 | Active comparator | Device: Biolimus A9-eluting Biomatrix stentBiolimus A9-eluting Biomatrix stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xience V everolimus eluting stentXience V everolimus eluting stent | Device | 1 |
| Biolimus A9-eluting Biomatrix stentBiolimus A9-eluting Biomatrix stent | Device | 2 |
Primary outcome
Stent strut coverage and stent strut apposition, assessed with OCT
Time frame: 9 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xience V everolimus eluting stent and Biolimus A9-eluting Biomatrix stent in people with Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent strut coverage and stent strut apposition, assessed with OCT (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.