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Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis

NCT00647504 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2011-09-12

No results posted yet for this study

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).

Study hypothesis:

Initial Stent implantation quality (due to technique/problems) are possible major determinants of ST and ISR in real life practice.

Both early, late, and very late ST, and ISR are important factors for long term outcome after initial stent implantation.

Primary objective:

* To elucidate the possible cause(s) of thrombosis or restenosis after stent implantation in real life practice by clinical, angiographic and IVUS evaluation.

Secondary objective:

* To describe the clinical manifestation \[stable angina pectoris (AP), unstable AP, non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation MI\] of the index event (inclusion).
* To describe the characteristics of patient, lesion and procedure of the initial percutaneous coronary intervention (PCI).
* To describe the antithrombotic pharmacological therapy preceding the index event.
* To describe clinical outcome (death, MI, revascularization, CCS angina class) following treatment of the index event during 12 month follow-up.
* To describe safety of the IVUS procedure (product or procedural related complications/ malfunctions).

Conditions

  • Stent Thrombosis
  • Restenosis

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Tampere University

    lead OTHER

Principal Investigators

  • Kari Niemelä, MD, CEO · Heart Center, Tampere University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-03-31
Completion
2011-03-31

Countries

  • Denmark
  • Finland
  • Latvia
  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00647504 on ClinicalTrials.gov