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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Saila Vikman, University of Tampere
ClinicalTrials.gov Identifier:
NCT00647504
First received: March 26, 2008
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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
Stent Thrombosis
Restenosis

Study Type: Observational
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)

Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Tabulation and classification of IVUS outcomes [ Time Frame: first day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 450
Study Start Date: October 2007
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Restenosis in Bare metal stent
2
Restenosis in Drug eluting stent
3
Stent thrombosis
4
Control group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

10-15 Nordic high volume PCI centers with experience in IVUS.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647504

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

No publications provided by University of Tampere

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saila Vikman, MD,, University of Tampere
ClinicalTrials.gov Identifier: NCT00647504     History of Changes
Other Study ID Numbers: R07054
Study First Received: March 26, 2008
Last Updated: September 9, 2011
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 22, 2014