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

This study is currently recruiting participants.
Verified April 2009 by University Hospital, Gasthuisberg
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01065519
First received: February 8, 2010
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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).


Condition Intervention
Coronary Artery Disease
Device: Xience V everolimus eluting stent
Device: Biolimus A9-eluting Biomatrix stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Stent strut coverage and stent strut apposition, assessed with OCT [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065519

Contacts
Contact: Tom Adriaenssens, MD +32 16 34 24 65 tom.adriaenssens@uzleuven.be
Contact: Walter Desmet, MD, PhD +32 16 34 24 65 walter.desmet@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Tom Adriaenssens, MD    +32 16 34 24 65    tom.adriaenssens@uzleuven.be   
Contact: Walter Desmet, MD, PhD    +32 16 34 24 65    walter.desmet@uzleuven.be   
Principal Investigator: Tom Adriaenssens, MD         
Sub-Investigator: Walter Desmet, MD, PhD         
Sub-Investigator: Christophe Dubois, MD         
Sponsors and Collaborators
University Hospital, Gasthuisberg
  More Information

No publications provided

Responsible Party: Cardiology Department University Hospitals Leuven, Belgium
ClinicalTrials.gov Identifier: NCT01065519     History of Changes
Other Study ID Numbers: EudraCT 2009-010923-14
Study First Received: February 8, 2010
Last Updated: February 8, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
Coronary stent
Optical coherence tomography
Intravascular ultrasound

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 20, 2014