Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03734549
Status:
UNKNOWN
Last Update Posted:
2018-11-08
First Post:
2018-06-26
Brief Title:
Predicting Procedural and Long-term Outcomes of Endovascular Revascularization for Lower Extremity Peripheral Artery Chronic Total Occlusions With Computed Tomographic Angiography
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
Predicting Procedural and Long-term Outcomes of Endovascular Revascularization for Lower Extremity Peripheral Artery Chronic Total Occlusions With Computed Tomographic Angiography
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nearly one-half of all lower extremity percutaneous interventions performed in patients with symptomatic peripheral artery disease PAD involve chronic total occlusions CTOs which are technically more challenging and are associated with more periprocedural complications and lower rates of procedural success comparing with non CTOs Despite innovate dedicated CTO devices developed and provides higher technical success a wire-catheter approach to cross peripheral artery CTO is most often the first choice of operators as its lower cost advantageSubhash Banerjee MD reported of all 1362 CTOs wire-catheter approaches were used in 82 and the technical success rate was 65 If the operators chose wire-catheter as primary crossing device at the beginning of the procedure but the technically failed with the provisional use of re-entry or crossing devices to try to procedural success Such procedures add incrementally to procedure duration and cost and the revascularization and amputation rate at 12 month were highly increased comparing with using dedicated CTO devices initially So it is very important to predict the outcome of guidewire crossing through CTOs to direct the choice of crossing strategy
Current data suggested that computed tomography angiography CTA imaging of PAD and a detailed comprehensive assessment for CTO arteries before endovascular therapy can assist preprocedural planning to maximize procedural success Previous studies about coronary CTOs prediction scores as the KCCT score and CT-based CT-RECTOR provide the factors including occlusion length the shape of proximal entry site severe calcification and etc characters base on CTA correlating with the outcome of cross As the same physiopathologic mechanism we hypothesized that the radiographic characteristics are connected with outcomes of guidewire crossing occlusions To our knowledge few studies focused on how to predict the successful GC through peripheral artery CTO therefore the purpose of this study was to establish a simple and clinically applicable prediction model based on CTA characters within the occlusive lesions and clinical parameters to predict the GC outcomes of patients with lower extremity CTO
In addition the long-term effect of endovascular revascularization are very important An analysis concluded that limb adverse event repeat revascularization rate 172 amputation rates 85 at 12-month in the CTOs with direct wire-catheter crossing strategy Base on the proven influence factors the lesion length small diameter of the vessel and severe calcification mechanical exposure etcof adverse event at after endovascular revascularization we also can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients biochemical and clinical feature to predict the adverse event rate at 12-month after endovascular revascularization
Current data suggested that computed tomography angiography CTA imaging of PAD and a detailed comprehensive assessment for CTO arteries before endovascular therapy can assist preprocedural planning to maximize procedural success Previous studies about coronary CTOs prediction scores as the KCCT score and CT-based CT-RECTOR provide the factors including occlusion length the shape of proximal entry site severe calcification and etc characters base on CTA correlating with the outcome of cross As the same physiopathologic mechanism we hypothesized that the radiographic characteristics are connected with outcomes of guidewire crossing occlusions To our knowledge few studies focused on how to predict the successful GC through peripheral artery CTO therefore the purpose of this study was to establish a simple and clinically applicable prediction model based on CTA characters within the occlusive lesions and clinical parameters to predict the GC outcomes of patients with lower extremity CTO
In addition the long-term effect of endovascular revascularization are very important An analysis concluded that limb adverse event repeat revascularization rate 172 amputation rates 85 at 12-month in the CTOs with direct wire-catheter crossing strategy Base on the proven influence factors the lesion length small diameter of the vessel and severe calcification mechanical exposure etcof adverse event at after endovascular revascularization we also can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients biochemical and clinical feature to predict the adverse event rate at 12-month after endovascular revascularization
Detailed Description:
Patients Patients with peripheral artery disease met the inclusion criteria if they were PAD patients had performed preprocedural CTA and PTA The hospitals database was used to identify the patients met inclusion criteria The medical records and radiologic information system database were reviewed to retrieve clinical information including background diseases and radiographic findings
Computed Tomography Angiography Protocol A 128-section multidetector CT Philips brillianceiCT was used for scanning with the following scanning parameterstube voltage was 120 kVp tube current 40-440mA and 0625-mm slice thicknesses The protocols required patients to lie supine with legs extended A fixed bolus of contrast medium with total volume of 90 ml 370 mg iodine per milliliter was injected into antecubital vein at a rate of 4 mLsec followed by a 30 mL saline flush by using a dual-barrel power injector CT scanning was performed with the coverage from the common iliac artery bifurcation to the tiptoe Scanning began 12 seconds after an attenuation threshold of 150 HU was reached
CTA Data Analysis CTA data were transferred to an offline workstation for further analysis Axial images cross-sectional views curved planar reformations CPR and multiplanar reformations MPR as well as three-dimensional maximum intensity projection images were available for evaluation We measure the degree of transluminal calcification CT attenuation value of the proximal occlusion anatomic distribution of the leisionand length of occlusionand the degree of stenosis CTO Crossing Strategy CTO crossing strategy was wire-catheter Technical success was defined as crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiographyOutcomes include binary variables of lesion crossing described as technical success or failure
Follow-up We also examined patient adverse events after procedures at 12 months all-cause deathnonfatal myocardial infarctionrevascularization and amputation
Built prediction model we can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients biochemical and clinical feature to predict the procedural and long-term outcomes of endovascular revascularization for Lower extremity peripheral artery chronic total occlusions
Computed Tomography Angiography Protocol A 128-section multidetector CT Philips brillianceiCT was used for scanning with the following scanning parameterstube voltage was 120 kVp tube current 40-440mA and 0625-mm slice thicknesses The protocols required patients to lie supine with legs extended A fixed bolus of contrast medium with total volume of 90 ml 370 mg iodine per milliliter was injected into antecubital vein at a rate of 4 mLsec followed by a 30 mL saline flush by using a dual-barrel power injector CT scanning was performed with the coverage from the common iliac artery bifurcation to the tiptoe Scanning began 12 seconds after an attenuation threshold of 150 HU was reached
CTA Data Analysis CTA data were transferred to an offline workstation for further analysis Axial images cross-sectional views curved planar reformations CPR and multiplanar reformations MPR as well as three-dimensional maximum intensity projection images were available for evaluation We measure the degree of transluminal calcification CT attenuation value of the proximal occlusion anatomic distribution of the leisionand length of occlusionand the degree of stenosis CTO Crossing Strategy CTO crossing strategy was wire-catheter Technical success was defined as crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiographyOutcomes include binary variables of lesion crossing described as technical success or failure
Follow-up We also examined patient adverse events after procedures at 12 months all-cause deathnonfatal myocardial infarctionrevascularization and amputation
Built prediction model we can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients biochemical and clinical feature to predict the procedural and long-term outcomes of endovascular revascularization for Lower extremity peripheral artery chronic total occlusions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None