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Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome (BASE-CFR)

This study has been completed.
Sponsor:
Information provided by:
The Hospital District of Satakunta
ClinicalTrials.gov Identifier:
NCT01080872
First received: March 3, 2010
Last updated: May 4, 2011
Last verified: May 2011
History of Changes
  Purpose

The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.


Condition Intervention Phase
Acute Coronary Syndrome
 Device: CFR
 Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital District of Satakunta:

Primary Outcome Measures:
  • Coronary flow reserve (CFR) [ Time Frame: 6-8 months after stent implantation ] [ Designated as safety issue: Yes ]
    CFR at 6-8 months after stent implantation


Secondary Outcome Measures:
  • Coronary flow velocity [ Time Frame: at baseline and during adenosine-induced hyperemia ] [ Designated as safety issue: Yes ]
  • Association of CFR to unendotheliazed stent struts and stent malapposition [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Titanium-NO coated stent
Patients receiving titanium-nitride-oxide coated stents during the intervention.
 Device: CFR
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Other Name: Xience-V stent, Abbott vascular, USA
Everolimus eluting stent
Patients receiving everolimus eluting stents during the intervention.
 Device: CFR
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Other Name: Xience-V stent, Abbott vascular, USA

Detailed Description:

Objective: The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.

Design: BASE-CFR is a substudy of the larger randomized multicenter BASE-ACS trial comparing bio-active Titan stent to everolimus-eluting stent in patients with acute coronary syndrome. CFR assessment will be performed at 6-8 months after stent implantation at the same time with OCT assessment. In-stent restenosis will be ruled out using OCT.

Primary endpoint: CFR at 6-8 months after stent implantation.

Secondary endpoint: Coronary flow velocity at baseline and during adenosine-induced hyperemia 6-8 months after stent implantation..

Association of CFR to unendotheliazed stent struts and stent malapposition.

Enrollment: 40 patients (20 receiving BAS and 20 receiving EES).

Clinical site: Satakunta Central Hospital, Finland Turku University Hospital, Finland

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute coronary syndrome who were treated with BAS or EES during index PCI.

Criteria

Inclusion Criteria:

  • The patient is enrolled to the BASE-ACS trial. Treated culprit lesion is in the proximal or middle LAD
  • Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site

Exclusion Criteria:

  • Diabetes mellitus
  • Treated stent position other than LAD proximal or middle.
  • EF<30%
  • Bifurcation lesions
  • Renal impairment (creatinine >120 mmol/L)
  • No suitable anatomy for OCT scan or CFR measurement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080872

Locations
Finland
Satakunta Central Hospital
Pori, Finland, 28500
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
The Hospital District of Satakunta
Investigators
Study Chair: Tuomas O Kiviniemi, MD PhD Satakunta Central Hospital
Study Chair: Antti Saraste, MD PhD Turku University Hospital
Principal Investigator: Pasi P Karjalainen, MD PhD Satakunta Central Hospital
Study Director: Antti Ylitalo, MD PhD Satakunta Central Hospital
Study Chair: Jussi Mikkelsson, MD PhD Satakunta Central Hospital
  More Information

Publications:

Responsible Party: Pasi Karjalainen, MD PhD, Satakunta Central Hospital
ClinicalTrials.gov Identifier: NCT01080872     History of Changes
Other Study ID Numbers: SA-005
Study First Received: March 3, 2010
Last Updated: May 4, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by The Hospital District of Satakunta:
acute coronary syndrome
coronary flow reserve
OCT
healing
drug eluting stent

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
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 May 22, 2013