Atherosclerosis Clinical Trial
Official title:
Optical Coherence TomOgraphy Assessment of the Excel Drug-Eluting Stent With BiodegradablE polymeR vs. the Cypher Drug-Eluting Stent With Permanent Polymer
BACKGROUND Treatment of coronary atherosclerotic disease has been significantly advanced by
interventional cardiology, and the advent of coronary arterial stents. In comparison to
angioplasty alone, stents have reduced the incidence of angiographic as well as clinical
restenosis, the recurrence of angina, the need for coronary arterial bypass graft (CABG)
surgery, repeat revascularization and the occurrence of major adverse cardiac events
(MACE).However the long-term success of this therapy has been limited by the occurrence of
in-stent restenosis. Despite the effectiveness of intracoronary stents in maintaining a
larger luminal diameter, as compared to angioplasty alone, in-stent restenosis occurs within
6 to 9 months after stent placement in 15% to 35% of patients. While stents can reduce
restenosis by blocking vascular recoil and remodeling, mechanical intervention alone has
been incapable of treating this biological problem of neointimal hyperplasia, particularly
in the subset of patients with diabetes, long lesions or small vessel disease.Drug-eluting
stents (DES) were developed as a viable method for focused delivery of anti-restenosis
compounds to target lesions for the reduction of restenosis. Of the DES available and with
the results of up to six (6) years clinical follow-up, the sirolimus-eluting stent (SES) has
become the current gold standard for stent implantation. With the advent of using DES to
treat complex lesions such as longer lesions requiring the use of multiple stents and the
use in bifurcation lesions, the risk of stent thrombosis has increase.Late stent thrombosis
has also been reported following DES implantation.Long term treatment with dual
anti-platelet therapy following stent implantation has become the solution used to
counteract the risk of stent thrombosis, this solution does not come without it's own risks
and is an expensive therapy. Another specific problem of DES is delayed endothelization, and
this may be and attributing factor in prolonging the period of thrombotic risk as shown by
pathological findings at autopsy following SES implantation. These examinations have shown
that even after 16 months, neointimal healing is still incomplete with approximately 20% of
stent struts being found uncovered. Questions have arose that the problems of late
thrombosis and delayed endothelization of stent struts with DES could be the result of the
permanent polymer that is used as the bonding agent for the anti-restenosis compounds to the
stents.Intravascular Ultrasound (IVUS) along with angiography has been the techniques used
to gain data on DES to this point. Angiography is a 2 dimensional tool that gives a view of
the vessel and IVUS gives a more 3 dimensional view of the vessel. IVUS does have its
limitations, as stent struts are reflectors of sonic waves, shadowing around and behind the
struts occurs. IVUS is also limited in detecting malapposition of the struts to the vessel
wall especially if the area between the vessel wall and the strut in very small.
RATIONALE Optical Coherence Tomography (OCT) is an optical analogue of IVUS that uses an
infrared light source and measures the backscatter of the light. With this technique a
higher level of resolution compared with IVUS has been reported.OCT has been reported as
being able to visualize and detect atherosclerotic plaques and assess more accurately strut
malapposition and the presence or thickness of neointimal hyperplasia as compared to IVUS.
With the question of delayed endothelization due to the permanent polymer being a probable
risk for late stent thrombosis, it is felt that OCT post stent implantation may give a more
accurate assessment of stent strut endothelial coverage.
This study is designed to compare the intimal hyperplasia following implantation of the
Excel DES with a biodegradable polymer vs. the Cypher DES with a permanent polymer using
OCT.
n/a
Observational Model: Case Control, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05052918 -
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
|
N/A | |
Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
|
N/A | |
Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Suspended |
NCT02932176 -
Machine Learning for Handheld Vascular Studies
|
||
Recruiting |
NCT05158257 -
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
|
N/A | |
Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
Recruiting |
NCT06230406 -
T-Mem GEne in Atherosclerosis
|
||
Completed |
NCT03654313 -
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
|
Phase 1 | |
Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
Recruiting |
NCT02894931 -
Effects of Dietary Interventions on Serum and Macrophage Atherogenicity
|
N/A | |
Completed |
NCT02998918 -
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
|
N/A | |
Not yet recruiting |
NCT02578355 -
National Plaque Registry and Database
|
N/A | |
Recruiting |
NCT02265250 -
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
|
||
Completed |
NCT03393377 -
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
|
N/A | |
Completed |
NCT02224339 -
New Technologies to Determine Carotid Plaque Vulnerability
|
||
Completed |
NCT02268513 -
Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
|
||
Not yet recruiting |
NCT01923012 -
Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
|
Phase 2 | |
Completed |
NCT02116829 -
Is There Room for Butter in a Healthy Diet?
|
N/A |