Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06127134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-11-07
Brief Title:
Outcomes of Straight-line Flow Versus Angiosome-targeted Angioplasty in Treatment of Critical Lower Limb Ischemia
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Outcomes of Straight-line Flow Versus Angiosome-targeted Angioplasty in Treatment of Critical Lower Limb Ischemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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:
Peripheral arterial disease PAD affects more than 200 million people worldwide Although over 50 are asymptomatic it accounts for 4 of all amputations
The ischemic limb must be revascularized to help wound healing reduce the pain of ischemia and preserve the limbs function So surgical and percutaneous revascularization choices must be considered in CLI Classically CLI revascularization aims to provide at least one patent vessel that delivers in-line flow to the foot
Today the investigators live in a new era of angioplasty evolving and substituting open vascular surgery so expanding research on endovascular strategy has been noticedThis confirms the profound impact of angioplasty in vascular surgery as one of the fastest-growing branches of medicine
Infrapopliteal artery occlusive disease IPOD is a significant cause of critical limb-threatening ischemia CLTI The worldwide prevalence of IPOD is between 45 and 29 and most patients live in low-income countries
The angiosomal concept was derived from plastic surgery for the skin flap This concept delineates the human body into three-dimensional blocks of tissue from the skin to bone and also provides practical application of vascular anatomy for reconstructive surgery An angiosome is an anatomic unit of tissue consisting of skin subcutaneous muscle and bone fed by a source artery and drained by a specific vein
According to the angiosomal concept the foot is divided into six distinct angiosomes fed by source arteries three from the posterior tibial two from the peroneal and one from the anterior tibial artery with functional artery-to-artery connections among muscle fascia and skin Numerous direct inter-arterial connections occur between the foots main arteries which provide alternative pathways of blood flow when disruption or compromise affects the arteries that directly feed the angiosome
On the other hand in patients with CLI where only one vessel runoff can be established to the foot direct flow into a patent pedal arch is essential to improve their clinical outcomes
Conventional Endovascular therapy aims to the re-establishment of pulsatile straight-line flow to the lower limb This results in relieving ischemic pain healing ulcers achieving limb salvage improving quality of life and potentially prolonging survival
So it became essential to know the differential impact of both concepts on CLI revascularization
The ischemic limb must be revascularized to help wound healing reduce the pain of ischemia and preserve the limbs function So surgical and percutaneous revascularization choices must be considered in CLI Classically CLI revascularization aims to provide at least one patent vessel that delivers in-line flow to the foot
Today the investigators live in a new era of angioplasty evolving and substituting open vascular surgery so expanding research on endovascular strategy has been noticedThis confirms the profound impact of angioplasty in vascular surgery as one of the fastest-growing branches of medicine
Infrapopliteal artery occlusive disease IPOD is a significant cause of critical limb-threatening ischemia CLTI The worldwide prevalence of IPOD is between 45 and 29 and most patients live in low-income countries
The angiosomal concept was derived from plastic surgery for the skin flap This concept delineates the human body into three-dimensional blocks of tissue from the skin to bone and also provides practical application of vascular anatomy for reconstructive surgery An angiosome is an anatomic unit of tissue consisting of skin subcutaneous muscle and bone fed by a source artery and drained by a specific vein
According to the angiosomal concept the foot is divided into six distinct angiosomes fed by source arteries three from the posterior tibial two from the peroneal and one from the anterior tibial artery with functional artery-to-artery connections among muscle fascia and skin Numerous direct inter-arterial connections occur between the foots main arteries which provide alternative pathways of blood flow when disruption or compromise affects the arteries that directly feed the angiosome
On the other hand in patients with CLI where only one vessel runoff can be established to the foot direct flow into a patent pedal arch is essential to improve their clinical outcomes
Conventional Endovascular therapy aims to the re-establishment of pulsatile straight-line flow to the lower limb This results in relieving ischemic pain healing ulcers achieving limb salvage improving quality of life and potentially prolonging survival
So it became essential to know the differential impact of both concepts on CLI revascularization
Detailed Description:
Introduction
Peripheral arterial disease PAD affects more than 200 million people worldwide Although over 50 are asymptomatic it accounts for 4 of all amputations
The ischemic limb must be revascularized to help wound healing reduce the pain of ischemia and preserve the limbs function So surgical and percutaneous revascularization choices must be considered in CLI Classically CLI revascularization aims to provide at least one patent vessel that delivers in-line flow to the foot
Today the investigators live in a new era of angioplasty evolving and substituting open vascular surgery so expanding research on endovascular strategy has been noticedThis confirms the profound impact of angioplasty in vascular surgery as one of the fastest-growing branches of medicine
Infrapopliteal artery occlusive disease IPOD is a significant cause of critical limb-threatening ischemia CLTI The worldwide prevalence of IPOD is between 45 and 29 and most patients live in low-income countries
The angiosomal concept was derived from plastic surgery for the skin flap This concept delineates the human body into three-dimensional blocks of tissue from the skin to bone and also provides practical application of vascular anatomy for reconstructive surgery An angiosome is an anatomic unit of tissue consisting of skin subcutaneous muscle and bone fed by a source artery and drained by a specific vein
According to the angiosomal concept the foot is divided into six distinct angiosomes fed by source arteries three from the posterior tibial two from the peroneal and one from the anterior tibial artery with functional artery-to-artery connections among muscle fascia and skin Numerous direct inter-arterial connections occur between the foots main arteries which provide alternative pathways of blood flow when disruption or compromise affects the arteries that directly feed the angiosome
On the other hand in patients with CLI where only one vessel runoff can be established to the foot direct flow into a patent pedal arch is essential to improve their clinical outcomes
Conventional Endovascular therapy aims to the re-establishment of pulsatile straight-line flow to the lower limb This results in relieving ischemic pain healing ulcers achieving limb salvage improving quality of life and potentially prolonging survival
So it became essential to know the differential impact of both concepts on CLI revascularization
Aim of the work Comparing the efficiency of two percutaneous transluminal angioplasty techniques for Critical Lower Limb Ischemia revascularization Straight-line flow Group A versus Angiosome-targeted Group BAs regard short-term impact
Patient and methods
1 Study Ethics the investigators will conduct this study after the approval of the IRB Institutional Review Board of Kafrelsheikh University Hospital All included procedures will be according to the Declaration of Helsinki the investigators will also obtain the patients informed consent to use their data in their research All evaluation forms reports and other records that leave the site would not include unique personal data to maintain subject confidentiality
2 Study design a non-randomized clinical trial
3 Time of study The study will be conducted in 2023
4 all patients will be submitted to the following preoperative evaluation 1-History 1 Personal data 2 Risk factors smoking DM hypertension hypercholesterolemia 3 Co-morbidity previous stroke angina MI and CKD 4 Previous PAD interventions to one or both legs 5 Previous amputations 6 Previous coronary intervention CABG PCI 2- Physical examination including
1 Assessment of functional status independent stick walker prosthesis wheelchair bed-bound 2 Recording of peripheral pulses 3 Measurement of ABPI or TBPI 4 Wound assessment in those patients with tissue loss 5 Assessment of ischaemic nightrest pain 3-Investigations A Laboratory
1 Routine hematology hemoglobin white cell count platelet count HbA1c
2 Routine biochemistry creatinine estimated GFR ESR CRP RBS cholesterol HBA1c
3 PT PTT INR
4 Lipid profile
BImaging of their arteries by one or more of the following modalities
1 Duplex ultrasound
2 Computerized tomography angiography CTA
3 Magnetic resonance angiography MRA
4 Digital subtraction angiography DUS
5 Patients with critical lower limb ischemia are going to be classified according to
Modified TASC II classification 2016 Trans-Atlantic Inter-society Consensus which is a morphological classification
Rutherford classification which is the clinical classification
6 Surgical procedure Therapeutic intervention angioplasty
7 Post-operative follow-up
Follow-up of the patients will be at the first third and sixth months from the intervention date Progress of limb conditions after the intervention will be observed which will be regarding
Diminution or absence of rest pain
Healing of ulcers
limb salvage Assessed by Visual Analogue Scale VAS
complications
8 Sampling technique
The sample size of 100 patients classified into two groups
9 Statistical analysis
Analysis of data will be done using SPSS statistical package for social science
10 Inclusion Criteria
Patient with documented symptomatic infragenicular chronic arterial disease with or without supra-genicular lesion
Diabetic or not
Rutherford grades 4 5 and 6
The patient is able and willing to comply with study follow-up requirements
11 Exclusion Criteria
Contraindication for angioplasty
unsuitable for angioplasty revascularization strategy
claudication case
tissue loss is considered to be primarily of venous etiology
Patient with full-thickness gangrene of the foot
Widespread infection of the lower limb needing amputation
12 Outcome Measures
Technical success as documented by angiography pre post procedure with residual stenosis 30
Clinical success is improving at least one class in Rutherford classification in patients with chronic limb ischemia
Primary patency at six months follow-up
Successful target lesion revascularization
The absence of major adverse events is defined as unplanned major amputation of the index limb
Absence of non-managed complications
Peripheral arterial disease PAD affects more than 200 million people worldwide Although over 50 are asymptomatic it accounts for 4 of all amputations
The ischemic limb must be revascularized to help wound healing reduce the pain of ischemia and preserve the limbs function So surgical and percutaneous revascularization choices must be considered in CLI Classically CLI revascularization aims to provide at least one patent vessel that delivers in-line flow to the foot
Today the investigators live in a new era of angioplasty evolving and substituting open vascular surgery so expanding research on endovascular strategy has been noticedThis confirms the profound impact of angioplasty in vascular surgery as one of the fastest-growing branches of medicine
Infrapopliteal artery occlusive disease IPOD is a significant cause of critical limb-threatening ischemia CLTI The worldwide prevalence of IPOD is between 45 and 29 and most patients live in low-income countries
The angiosomal concept was derived from plastic surgery for the skin flap This concept delineates the human body into three-dimensional blocks of tissue from the skin to bone and also provides practical application of vascular anatomy for reconstructive surgery An angiosome is an anatomic unit of tissue consisting of skin subcutaneous muscle and bone fed by a source artery and drained by a specific vein
According to the angiosomal concept the foot is divided into six distinct angiosomes fed by source arteries three from the posterior tibial two from the peroneal and one from the anterior tibial artery with functional artery-to-artery connections among muscle fascia and skin Numerous direct inter-arterial connections occur between the foots main arteries which provide alternative pathways of blood flow when disruption or compromise affects the arteries that directly feed the angiosome
On the other hand in patients with CLI where only one vessel runoff can be established to the foot direct flow into a patent pedal arch is essential to improve their clinical outcomes
Conventional Endovascular therapy aims to the re-establishment of pulsatile straight-line flow to the lower limb This results in relieving ischemic pain healing ulcers achieving limb salvage improving quality of life and potentially prolonging survival
So it became essential to know the differential impact of both concepts on CLI revascularization
Aim of the work Comparing the efficiency of two percutaneous transluminal angioplasty techniques for Critical Lower Limb Ischemia revascularization Straight-line flow Group A versus Angiosome-targeted Group BAs regard short-term impact
Patient and methods
1 Study Ethics the investigators will conduct this study after the approval of the IRB Institutional Review Board of Kafrelsheikh University Hospital All included procedures will be according to the Declaration of Helsinki the investigators will also obtain the patients informed consent to use their data in their research All evaluation forms reports and other records that leave the site would not include unique personal data to maintain subject confidentiality
2 Study design a non-randomized clinical trial
3 Time of study The study will be conducted in 2023
4 all patients will be submitted to the following preoperative evaluation 1-History 1 Personal data 2 Risk factors smoking DM hypertension hypercholesterolemia 3 Co-morbidity previous stroke angina MI and CKD 4 Previous PAD interventions to one or both legs 5 Previous amputations 6 Previous coronary intervention CABG PCI 2- Physical examination including
1 Assessment of functional status independent stick walker prosthesis wheelchair bed-bound 2 Recording of peripheral pulses 3 Measurement of ABPI or TBPI 4 Wound assessment in those patients with tissue loss 5 Assessment of ischaemic nightrest pain 3-Investigations A Laboratory
1 Routine hematology hemoglobin white cell count platelet count HbA1c
2 Routine biochemistry creatinine estimated GFR ESR CRP RBS cholesterol HBA1c
3 PT PTT INR
4 Lipid profile
BImaging of their arteries by one or more of the following modalities
1 Duplex ultrasound
2 Computerized tomography angiography CTA
3 Magnetic resonance angiography MRA
4 Digital subtraction angiography DUS
5 Patients with critical lower limb ischemia are going to be classified according to
Modified TASC II classification 2016 Trans-Atlantic Inter-society Consensus which is a morphological classification
Rutherford classification which is the clinical classification
6 Surgical procedure Therapeutic intervention angioplasty
7 Post-operative follow-up
Follow-up of the patients will be at the first third and sixth months from the intervention date Progress of limb conditions after the intervention will be observed which will be regarding
Diminution or absence of rest pain
Healing of ulcers
limb salvage Assessed by Visual Analogue Scale VAS
complications
8 Sampling technique
The sample size of 100 patients classified into two groups
9 Statistical analysis
Analysis of data will be done using SPSS statistical package for social science
10 Inclusion Criteria
Patient with documented symptomatic infragenicular chronic arterial disease with or without supra-genicular lesion
Diabetic or not
Rutherford grades 4 5 and 6
The patient is able and willing to comply with study follow-up requirements
11 Exclusion Criteria
Contraindication for angioplasty
unsuitable for angioplasty revascularization strategy
claudication case
tissue loss is considered to be primarily of venous etiology
Patient with full-thickness gangrene of the foot
Widespread infection of the lower limb needing amputation
12 Outcome Measures
Technical success as documented by angiography pre post procedure with residual stenosis 30
Clinical success is improving at least one class in Rutherford classification in patients with chronic limb ischemia
Primary patency at six months follow-up
Successful target lesion revascularization
The absence of major adverse events is defined as unplanned major amputation of the index limb
Absence of non-managed complications
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