Status:
COMPLETED
Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis
Lead Sponsor:
Tampere University
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Stent Thrombosis
Restenosis
Eligibility:
All Genders
18+ years
Brief Summary
Prospective clinical observational registry study including consecutive patients with clinical signs or symptoms due to in-stent restenosis (ISR) or definite (ARC criteria) stent thrombosis (ST). Stu...
Detailed Description
Investigational sites: 10-15 high volume Nordic PCI centres with experience in intravascular ultrasound (IVUS). Patients: * All consecutive patients admitted with an ischemic event due to ST (estim...
Eligibility Criteria
Inclusion
- All Consecutive consented patients with a suspected ST either with BMS or DES. (estimated number of patients \>100), admitted to one of the participating hospitals:
- Typical symptoms or evidence of myocardial ischemia (stable AP, UAP/NSTEMI, STEMI)
- Clinical suspicion of ST is based on the ARC criteria (probable ST). ST will be verified by coronary angiography.
- All consecutive patients with symptoms or signs of ischemia (angina pectoris, unstable angina, NSTEMI, STEMI, or documented myocardial ischemia) due to ISR with DES (target about 200 patients) and respective BMS patients up to maximum 100 patients.
Exclusion
- Informed consent cannot be obtained
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00647504
Start Date
October 1 2007
End Date
March 1 2011
Last Update
September 12 2011
Active Locations (5)
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1
Skejby Hospital
Aarhus, Denmark
2
Heart Center, Tampere University Hospital
Tampere, Finland, 33521
3
Riga Heart Center
Riga, Latvia
4
Ullevål University Hospital
Oslo, Norway