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Coronary DiseaseNCT00429052

Mechanism of Percutaneous Revascularization for Coronary Bifurcation Disease

An observational study of Coronary Disease, run by University of Florida at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main objectives of this study are define frequency of plaque shift phenomenon and impact on flow dynamics in the side branch as assessed by intravascular ultrasound, and evaluate acute and late side branch ostial vessel reaction to balloon angioplasty and drug-eluting stents. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Disease
How many people
24 participants
Where
1 siteUnited States
Study dates
Nov 2006to Sep 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: from cathet labs

Who may be able to join

  • Male or female patient between 18-80 years of age
  • Patients with a sign and/or symptoms of ischemia and new de novo lesion
  • Lesion suitable for stenting
  • Any bifurcation lesion with SB reference diameter(QCA) >2.3mm (MEDINA classification: 1,0,0; 0,1,0; 0,0,1; 1,1,0; 1,1,1; 0,1,1; 1,0,1)
  • Only elective procedures
  • Patient is willing to provide written informed consent

Who cannot join

  • Patients treated within 72h of acute coronary syndromes (ST and non-ST elevation MI).
  • Cardiogenic shock
  • Lesion containing thrombus
  • Total vessel occlusion involving the target vessels
  • Contraindication for prolonged antiplatelet treatment
  • Left main disease, venous or arterial graft disease
Show all 10Show fewer
  • Debulking technique used prior to the stent implantation
  • Pregnancy
  • Severe liver or renal disease (Cr>2.0)
  • Life expectancy < 1 year.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida Health Science Center, Cardiovascular Imaging Core Laboratories

    Jacksonville, Florida, 32209

Other trials in United States

About this study

Official title: Insights Into the Mechanism of Percutaneous Revascularization of Coronary Bifurcation Disease in the Drug-eluting Stent Era. An Angiographic and Intravascular Ultrasound Study. The INSIGHT Trial

The main objectives of this study are define frequency of plaque shift phenomenon and impact on flow dynamics in the side branch as assessed by intravascular ultrasound, and evaluate acute and late side branch ostial vessel reaction to balloon angioplasty and drug-eluting stents.

Read the detailed description

Percutaneous coronary intervention of bifurcation lesion remains a challenge, even in the era of drug eluting stents (DES). Bifurcation interventions, when compared with non-bifurcation interventions, have a lower rate of procedural success and a higher rate of restenosis regardless of the techniques or technologies used. Although stenting of individual non-bifurcated lesion has been shown to be superior to balloon angioplasty, stenting of both branches seems to offer no advantage over stenting of the main branch (MB) alone. The recent introduction of DES has resulted in a lower event rate and reduction of MB restenosis in comparison with historical controls. However, reports suggest that restenosis at the side branch (SB) ostium continues to be elevated. Intravascular ultrasound (IVUS) studies have shown that stent dimensions are important predictors of restenosis even with DES. Recently published observational data of IVUS analysis of bifurcation lesions treated with "crush" technique has shown the smallest minimum stent area at the SB ostium. This may contribute to a higher restenosis rate. Plaque shift and insufficient covering of the SB ostium may also play a major role in a development of SB restenosis. The belief that plaque shift occurs during bifurcation stenting is challenged by the fact that plaque is mainly located opposite to the side branch ostium as demonstrated by IVUS and anatomical studies. Further, the occurrence of plaque shift in bifurcation lesions has never been scientifically investigated. Finally, bending and twisting of the coronary arteries at the bifurcation should be taken into account in the mechanism of SB restenosis because of continuous vessel wall injury by the rigid stent and potential stent fractures. Bifurcation represents an extreme model of vessel bending and twisting because the vessels beyond the bifurcation are in different path/orientation and different heart walls. A better understanding of the mechanisms of bifurcation intervention and restenosis is essential for the development of a successful technique and dedicated technologies for this challenging scenario. Despite multiple retrospective studies and various ingenious techniques, a true prospective mechanistic investigation remains lacking in the field of bifurcation. The main objectives of this study are define frequency of plaque shift phenomenon and impact on flow dynamics in the side branch as assessed by IVUS, and evaluate acute and late side branch ostial vessel reaction to balloon angioplasty and DES.

Keywords
Coronary Disease, Coronary Stenosis, Percutaneous Transluminal Coronary Angioplasty, Stents, Sirolimus
Medical subject headings
Coronary Disease, Coronary Stenosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2007 (estimated)
  2. Study startNov 2006
  3. Study completionSep 2008

Why it stopped: PI left institution,inability to enroll and analyze data due to software/technical limitations, pt enrollment terminated early with no data generated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00429052
Sponsor's protocol ID
INS-C-001
Status last verified
Jan 2007
First submitted
30 Jan 2007
Last updated
7 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: PI left institution,inability to enroll and analyze data due to software/technical limitations, pt enrollment terminated early with no data generated). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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