Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis (NIVUS)
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).
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.
- To elucidate the possible cause(s) of thrombosis or restenosis after stent implantation in real life practice by clinical, angiographic and IVUS evaluation.
- 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).
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Nordic IVUS Study: 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)|
- Tabulation and classification of IVUS outcomes [ Time Frame: first day ] [ Designated as safety issue: No ]
- Clinical manifestation of the index event [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- IVUS procedure related events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
- Outcome of treatment during the 12 month follow-up: clinical status and major cardiac events [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
- Compliance to antithrombotic therapy [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
- Tabulation and classification of angiographic outcomes [ Time Frame: first day ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Restenosis in Bare metal stent
Restenosis in Drug eluting stent
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|Heart Center, Tampere University Hospital|
|Tampere, Finland, 33521|
|Riga Heart Center|
|Ullevål University Hospital|
|Lund University hospital|
|Principal Investigator:||Kari Niemelä, MD, CEO||Heart Center, Tampere University Hospital|