Mechanism of Percutaneous Revascularization for Coronary Bifurcation Disease

This study has been terminated.
(PI left institution,inability to enroll and analyze data due to software/technical limitations, pt enrollment terminated early with no data generated)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00429052
First received: January 30, 2007
Last updated: March 6, 2012
Last verified: January 2007
  Purpose

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.


Condition
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Enrollment: 24
Study Start Date: November 2006
Study Completion Date: September 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

from cathet labs

Criteria

Inclusion Criteria:

  1. Male or female patient between 18-80 years of age
  2. Patients with a sign and/or symptoms of ischemia and new de novo lesion
  3. Lesion suitable for stenting
  4. 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)
  5. Only elective procedures
  6. Patient is willing to provide written informed consent

Exclusion Criteria:

  1. Patients treated within 72h of acute coronary syndromes (ST and non-ST elevation MI).
  2. Cardiogenic shock
  3. Lesion containing thrombus
  4. Total vessel occlusion involving the target vessels
  5. Contraindication for prolonged antiplatelet treatment
  6. Left main disease, venous or arterial graft disease
  7. Debulking technique used prior to the stent implantation
  8. Pregnancy
  9. Severe liver or renal disease (Cr>2.0)
  10. Life expectancy < 1 year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429052

Locations
United States, Florida
University of Florida Health Science Center, Cardiovascular Imaging Core Laboratories
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Marco A Costa, MD, PhD University of Florida Shands Jacksonville, Division of Cardiology and Cardiovascular Imaging Core Laboratories
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00429052     History of Changes
Other Study ID Numbers: INS-C-001
Study First Received: January 30, 2007
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Coronary Disease
Coronary Stenosis
Percutaneous Transluminal Coronary Angioplasty
Stents
Sirolimus

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 26, 2014