Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01394848
Status:
TERMINATED
Last Update Posted:
2013-12-04
First Post:
2011-07-11
Brief Title:
Safety and Efficacy Study of Endothelial Progenitor Cell Capture Stent With 1 Months Dual Antiplatelet Therapy
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
EndothelIal progeNitor Cell Capture steNt With 1-mOnth Dual Antiplatelet Therapy Versus eVerolimus-eluting Stent With stAndard 12-month Dual anTIplatelet Therapy in Elderly 70 Year With Stable corONary Artery Disease - INNOVATION Trial
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Previous other study including EPC capture stent raised the issue of safety significant high incidence of instent restenosis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INNOVATION
Brief Summary:
Thanks to rapid reendothelialization derived from the pro-healing property of the EPC capture stent 1-month dual antiplatelet therapy DAPT is recommended after EPC capture stent implantation Shorter maintenance of dual antiplatelet therapy might minimize the risk for stent thrombosis in cases of discontinuation of antiplatelet regimen and prevent wasteful medications and bleeding complications related with dual antiplatelet therapy Thus the EPC capture stent might be valuable for the elderly because they are vulnerable to premature discontinuation of DAPT
On the other hand statin upstream therapy has gained popularity because it seems to reduce periprocedural myocardial injury especially in ACS through its pleiotrophic effect like plaque stabilization However the benefit of pretreatment of statin in patients with stable angina remains controversial It is reported that statin administration could increase EPC level by accelerated differentiation towards the endothelial progenitor lineage
We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is non-inferior to DES in the elderly subjects with stable coronary artery disease To test this hypothesis we will perform a multi-center randomized prospective trial aimed at demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in real world practice
On the other hand statin upstream therapy has gained popularity because it seems to reduce periprocedural myocardial injury especially in ACS through its pleiotrophic effect like plaque stabilization However the benefit of pretreatment of statin in patients with stable angina remains controversial It is reported that statin administration could increase EPC level by accelerated differentiation towards the endothelial progenitor lineage
We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is non-inferior to DES in the elderly subjects with stable coronary artery disease To test this hypothesis we will perform a multi-center randomized prospective trial aimed at demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in real world practice
Detailed Description:
Drug-eluting stents DES have improved angiographic and clinical outcomes in patients with the complex coronary lesions and high risks by markedly reducing the neointimal hyperplasia following stent implantation in comparison to bare-metal stents BMS Although the concerns about long-term safety and the occurrence of stent thrombosis following DES implantation had been raised the recent DES-registry studies have reported that DES did not increase the risk of death or stent thrombosis during follow-up as compared with BMS However currently the fatal events related with stent thrombosis still occur and are the major limitation of the use of DES Especially late or very late thrombosis after DES implantation is an uncommon but life-threatening fatal complication presented with sudden death or myocardial infarction MI
The most powerful predictor for stent thrombosis is the discontinuation of clopidogrel Then under these circumstances the prolonged dual antiplatelet therapy is now recommended irrespective of each precise consideration according to the types of DES lesion complexity or clinical characteristics Although the prolonged antiplatelet therapy can prevent stent thrombosis it might cause other problems such as combined bleeding complications high cost due to prolonged use and unnecessary maintenance of medication The stratified strategies regarding antiplatelet therapy according to the lesion complexity or high risks such as diabetes or acute coronary syndrome which were regarded as the most prominent predictors for stent thrombosis should be required Another difficult problem of DES in real world practice is how we can manage the cases in which clopidogrel should be discontinued due to unexpected minor and major operations or invasive procedures Because there have been no available substitutes as a bridging therapy of clopidogrel until operation many advisory groups recommend to hold on off elective non-cardiac surgery 12 months after DES implantation If not BMS implantation is strongly recommended for patients with high risk of bleeding or scheduled unavoidable surgery within the next 12 months Especially in the elderly premature discontinuation of DAPT within 12 months after PCI may occur due to combined co-morbid disease requiring surgical intervention decreased drug compliance or occurrence of gastrointestinal bleeding
Recently many attempts to elucidate the mechanism of stent thrombosis have been performed Finn AV et al have reported from the human autopsies of DES that the most powerful histological predictor of stent thrombosis was endothelial coverage and suggested stent strut coverage as a marker of endothelialization After then the more concerns have been focused on the healthy healing after DES implantation in spite of relatively higher late lumen loss As a result when antiplatelet therapy should be discontinued DES with a healthy healing might be more preferred instead of efficient DES with a lower late lumen loss
In the view of these points in spite of actual higher late lumen loss Endothelial Progenitor Cell EPC Capture Stent GENOUS Bio-engineered R stent OrbusNeich could be more beneficial and safer than DES because of its low risk for stent thrombosis due to more rapid endothelialization and its resulting short-term use of dual antiplatelet EPC capture stent has antibodies immobilized on the stent surface to capture circulating endothelial progenitor cells leading to accelerated natural healing Theoretically the EPC capture stent has two benefits It establish functional endothelium therefore no longer term anti-platelet therapy is required Second EPC capture stent may minimizes restenosis because it establishes healthy endothelium which expresses vasoactive compounds such as nitric oxide which modulates neo-intimal hyperplasia and thus restenosis
Thanks to rapid reendothelialization derived from the pro-healing property of the EPC capture stent 1-month dual antiplatelet therapy DAPT is recommended after EPC capture stent implantation Shorter maintenance of dual antiplatelet therapy might minimize the risk for stent thrombosis in cases of discontinuation of antiplatelet regimen and prevent wasteful medications and bleeding complications related with dual antiplatelet therapy Thus the EPC capture stent might be valuable for the elderly because they are vulnerable to premature discontinuation of DAPT
On the other hand statin upstream therapy has gained popularity because it seems to reduce periprocedural myocardial injury especially in ACS through its pleiotrophic effect like plaque stabilization However the benefit of pretreatment of statin in patients with stable angina remains controversial It is reported that statin administration could increase EPC level by accelerated differentiation towards the endothelial progenitor lineage
We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is non-inferior to DES in the elderly subjects with stable coronary artery disease To test this hypothesis we will perform a multi-center randomized prospective trial aimed at demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in real world practice
The most powerful predictor for stent thrombosis is the discontinuation of clopidogrel Then under these circumstances the prolonged dual antiplatelet therapy is now recommended irrespective of each precise consideration according to the types of DES lesion complexity or clinical characteristics Although the prolonged antiplatelet therapy can prevent stent thrombosis it might cause other problems such as combined bleeding complications high cost due to prolonged use and unnecessary maintenance of medication The stratified strategies regarding antiplatelet therapy according to the lesion complexity or high risks such as diabetes or acute coronary syndrome which were regarded as the most prominent predictors for stent thrombosis should be required Another difficult problem of DES in real world practice is how we can manage the cases in which clopidogrel should be discontinued due to unexpected minor and major operations or invasive procedures Because there have been no available substitutes as a bridging therapy of clopidogrel until operation many advisory groups recommend to hold on off elective non-cardiac surgery 12 months after DES implantation If not BMS implantation is strongly recommended for patients with high risk of bleeding or scheduled unavoidable surgery within the next 12 months Especially in the elderly premature discontinuation of DAPT within 12 months after PCI may occur due to combined co-morbid disease requiring surgical intervention decreased drug compliance or occurrence of gastrointestinal bleeding
Recently many attempts to elucidate the mechanism of stent thrombosis have been performed Finn AV et al have reported from the human autopsies of DES that the most powerful histological predictor of stent thrombosis was endothelial coverage and suggested stent strut coverage as a marker of endothelialization After then the more concerns have been focused on the healthy healing after DES implantation in spite of relatively higher late lumen loss As a result when antiplatelet therapy should be discontinued DES with a healthy healing might be more preferred instead of efficient DES with a lower late lumen loss
In the view of these points in spite of actual higher late lumen loss Endothelial Progenitor Cell EPC Capture Stent GENOUS Bio-engineered R stent OrbusNeich could be more beneficial and safer than DES because of its low risk for stent thrombosis due to more rapid endothelialization and its resulting short-term use of dual antiplatelet EPC capture stent has antibodies immobilized on the stent surface to capture circulating endothelial progenitor cells leading to accelerated natural healing Theoretically the EPC capture stent has two benefits It establish functional endothelium therefore no longer term anti-platelet therapy is required Second EPC capture stent may minimizes restenosis because it establishes healthy endothelium which expresses vasoactive compounds such as nitric oxide which modulates neo-intimal hyperplasia and thus restenosis
Thanks to rapid reendothelialization derived from the pro-healing property of the EPC capture stent 1-month dual antiplatelet therapy DAPT is recommended after EPC capture stent implantation Shorter maintenance of dual antiplatelet therapy might minimize the risk for stent thrombosis in cases of discontinuation of antiplatelet regimen and prevent wasteful medications and bleeding complications related with dual antiplatelet therapy Thus the EPC capture stent might be valuable for the elderly because they are vulnerable to premature discontinuation of DAPT
On the other hand statin upstream therapy has gained popularity because it seems to reduce periprocedural myocardial injury especially in ACS through its pleiotrophic effect like plaque stabilization However the benefit of pretreatment of statin in patients with stable angina remains controversial It is reported that statin administration could increase EPC level by accelerated differentiation towards the endothelial progenitor lineage
We hypothesize that the EPC capture stent with 1-month dual antiplatelet therapy is non-inferior to DES in the elderly subjects with stable coronary artery disease To test this hypothesis we will perform a multi-center randomized prospective trial aimed at demonstrating the efficacy and safety of the EPC capture stent with 1-month DATP versus EES with standard 12-month DAPT in elderly patients with stable coronary occlusive disease in real world practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None