NCT00647504

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 12, 2011

Status Verified

September 1, 2011

Enrollment Period

2.4 years

First QC Date

March 26, 2008

Last Update Submit

September 9, 2011

Conditions

Stent ThrombosisRestenosis

Keywords

stent thrombosisstent restenosisintravascular ultrasound

Outcome Measures

Primary Outcomes (1)

  • Tabulation and classification of IVUS outcomes

    first day

Secondary Outcomes (5)

  • Clinical manifestation of the index event

    12 months

  • IVUS procedure related events

    1 week

  • Outcome of treatment during the 12 month follow-up: clinical status and major cardiac events

    12 months follow-up

  • Compliance to antithrombotic therapy

    12 month follow-up

  • Tabulation and classification of angiographic outcomes

    first day

Study Arms (4)

1

Restenosis in Bare metal stent

2

Restenosis in Drug eluting stent

3

Stent thrombosis

4

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Informed consent cannot be obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Skejby Hospital

Aarhus, Denmark

Location

Heart Center, Tampere University Hospital

Tampere, 33521, Finland

Location

Riga Heart Center

Riga, Latvia

Location

Ullevål University Hospital

Oslo, Norway

Location

Lund University hospital

Lund, Sweden

Location

Related Publications (1)

  • Kosonen P, Vikman S, Jensen LO, Lassen JF, Harnek J, Olivecrona GK, Erglis A, Fossum E, Niemela M, Kervinen K, Ylitalo A, Pietila M, Aaroe J, Kellerth T, Saunamaki K, Thayssen P, Hellsten L, Thuesen L, Niemela K. Intravascular ultrasound assessed incomplete stent apposition and stent fracture in stent thrombosis after bare metal versus drug-eluting stent treatment the Nordic Intravascular Ultrasound Study (NIVUS). Int J Cardiol. 2013 Sep 30;168(2):1010-6. doi: 10.1016/j.ijcard.2012.10.033. Epub 2012 Nov 17.

    PMID: 23164593DERIVED

Study Officials

  • Kari Niemelä, MD, CEO

    Heart Center, Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

October 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2011

Last Updated

September 12, 2011

Record last verified: 2011-09

Locations

NO(1)SE(1)FI(1)DK(1)LA(1)