Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed,
and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government
operating status and resumption of normal operations can be found at opm.gov.
Mechanism of Percutaneous Revascularization for Coronary Bifurcation Disease
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00429052
(PI left institution,inability to enroll and analyze data due to software/technical limitations, pt enrollment terminated early with no data generated)
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 or disease
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.
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, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
from cathet labs
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
Patients treated within 72h of acute coronary syndromes (ST and non-ST elevation MI).
Lesion containing thrombus
Total vessel occlusion involving the target vessels
Contraindication for prolonged antiplatelet treatment
Left main disease, venous or arterial graft disease
Debulking technique used prior to the stent implantation