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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00647504
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : September 12, 2011
Boston Scientific Corporation
Information provided by (Responsible Party):
Saila Vikman, University of Tampere

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).

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).

Condition or disease
Stent Thrombosis Restenosis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 450 participants
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)
Study Start Date : October 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
U.S. FDA Resources

Restenosis in Bare metal stent
Restenosis in Drug eluting stent
Stent thrombosis
Control group

Primary Outcome Measures :
  1. Tabulation and classification of IVUS outcomes [ Time Frame: first day ]

Secondary Outcome Measures :
  1. Clinical manifestation of the index event [ Time Frame: 12 months ]
  2. IVUS procedure related events [ Time Frame: 1 week ]
  3. Outcome of treatment during the 12 month follow-up: clinical status and major cardiac events [ Time Frame: 12 months follow-up ]
  4. Compliance to antithrombotic therapy [ Time Frame: 12 month follow-up ]
  5. Tabulation and classification of angiographic outcomes [ Time Frame: first day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
10-15 Nordic high volume PCI centers with experience in IVUS.

Inclusion Criteria:

  • 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 Criteria:

  • Informed consent cannot be obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00647504

Skejby Hospital
Århus, Denmark
Heart Center, Tampere University Hospital
Tampere, Finland, 33521
Riga Heart Center
Riga, Latvia
Ullevål University Hospital
Oslo, Norway
Lund University hospital
Lund, Sweden
Sponsors and Collaborators
University of Tampere
Boston Scientific Corporation
Principal Investigator: Kari Niemelä, MD, CEO Heart Center, Tampere University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Saila Vikman, MD,, University of Tampere Identifier: NCT00647504     History of Changes
Other Study ID Numbers: R07054
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: September 2011

Keywords provided by Saila Vikman, University of Tampere:
stent thrombosis
stent restenosis
intravascular ultrasound

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases