Mechanism of Percutaneous Revascularization for Coronary Bifurcation Disease

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00429052
• Other study ID #: INS-C-001
• Status: Terminated
• Phase: N/A
• First received: January 30, 2007
• Last updated: March 6, 2012
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: January 2007
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
United States	University of Florida Health Science Center, Cardiovascular Imaging Core Laboratories	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States,