Critical Lower Limb IschemiaNCT05436405
Trans-pedal Access for Endovascular Revascularization in Complex Infra-popliteal Lesions in Critically Ischemic Limb
A study testing Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb in people with Critical Lower Limb Ischemia, run by Mansoura University at 1 site in Egypt.
Trial summary
Background: critical limb ischemia is one of the most challenging cases we face nowadays with high risk for amputation, retrograde trans-pedal angioplasty offers an alternative technique after failure of traditional ante-grade angioplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Lower Limb Ischemia
- What is being tested?
- Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients aged from (18-80) years, males and female
- patients with 1ry lesion (without previous trial of angioplasty or bypass)
- 2ry lesion (after previous trial of angioplasty or bypass),
- the patients with fountain classification (stage IIB, stage III, stage IV)
- patients with Rutherford classification (grade I "category 3", grade II, Category 4", grade III, Category 4\&category 5.
Who cannot join
- patients with untreated osteomyelitis,
- patients with mixed lesions with other comorbidities (CVI \& Lymphoedema),
- patients with vasculitis or Buerger's dis.
- Also, who can't give consent (mentally retarded patients) or those with behavioral disorders .
Trial locations and contacts
1 site in 1 country.
About this study
Background: critical limb ischemia is one of the most challenging cases we face nowadays with high risk for amputation, retrograde trans-pedal angioplasty offers an alternative technique after failure of traditional ante-grade angioplasty.
Patients and Methods: 96 patients underwent trans-pedal or trans-tibial retrograde angioplasty after failure of the traditional ante-grade angioplasty with the aid of US, 21-gauge needle and 0.018 wire through sheath-less approach as a last chance for revascularization
Read the detailed description
Study Design: This prospective non randomized study that had been performed at vascular surgery department at Mansoura University Hospital between March 2018 and April 2020, who was selected for 96patients undergoing endovascular BTK revascularization for CLI owing to tibial vascular diseases and gave written informed consent. Such cases who not give good response following traditional ante-grade ipsilateral trans-femoral approach and consequently underwent retrograde Trans-pedal or transtibial access to provide endovascular management for the lesions.
Inclusion criteria:
- all patients aged from (18-80) years, males and female
- patients with 1ry lesion (without previous trial of angioplasty or bypass)
- 2ry lesion (after previous trial of angioplasty or bypass),
- the patients with fountain classification (stage IIB, stage III, stage IV)
- patients with Rutherford classification (grade I "category 3", grade II, Category 4", grade III, Category 4\&category 5.
Exclusion criteria:
- patients with untreated osteomyelitis,
- patients with mixed lesions with other comorbidities (CVI \& Lymphoedema),
- patients with vasculitis or Buerger's dis.
- Also, who can't give consent (mentally retarded patients) or those with behavioral disorders .
Study tools History Data: included patient's demographics, underlying medical conditions, any previous surgery, transplanted kidney and other associated morbidity.
Examination: Full arterial assessments included pulse examination, and the ABPI (ankle brachial pressure index).
Laboratory: Blood picture, Blood sugar level, Kidney functions, Liver functions and Coagulation profile.
Imaging: Duplex ultra-sonographic (US) examination and CTA. Technique: Entire cases underwent full therapeutic medication prior to interference. Entire cases were tried ante-grade re-vascularization with a subsequent failure. A lower limb angiogram was be ready in entire cases prior to the retrograde procedure performance. Briefly, conventional femoral access will be conducted in the traditional manner and involve the sheath while the catheter was introduced close to the proximal degree of lesion.
Access to a pedal vessel: Using a 21-guage needle with insertion of 0.018-inch wire by sheathless technique (Figure 1) or by utilizing a micro puncture access set. A duplex-guided access has a great importance in terms of evaluation of the pedal as well as tibial blood vessels. Such vessel is recognized using the US probe. Color flow is utilized for identification of the objective artery flow, after that color disappeared while the needle is utilized for accessing the anterior vascular surface by utilizing duplex US , such approach performed in 54 patients. There are technical points worth mentioning utilizing such procedure: usage the smallest ready US as the major ones are bulky and may have a role in interference with the access process. In addition, marked vascular calcification may induce marked shadow making the identification very hard to be detected. In such conditions, a fluoroscopy might enable a good possibility for efficient access. In addition, it was suggested to utilize micro-puncture needle supposed to have echogenic pattern as the tip of regular needle is very hard to visualize utilizing the duplex US probe. Also, use of straight fluoroscopy or road mapping may offer a better chance for successful access, as we mentioned before, this method is done in 31 cases . Appropriate section of the actual place of vascular access is essential for the successfulness of such procedure. Generally, a patent vascular is selected to be the access situation. A micro-puncture needle is utilized for access. Occasionally, bending the needle tip has the ability to make the possibility of vascular evaluation easy which has great importance if the access point in the ATA beyond the ankle. Another method is open method (cut down) on tibial vessels, this method is done in 11 cases. Following evaluating the artery, established by back hemorrhage, the micro puncture access wire is introduced via the needle into the vessels underneath fluoroscopic guide in a retrograde fashion. The needle is removed and micro puncture set (4F) or the balloon itself is passed over the wire to secure the access. According to micro puncture introducer set it includes a 21- gauge, 7- cm echogenic needle, 10 - cm long micro puncture 4-french introducer and 2.9F inner caliber permitting passage of the equipment. When the retrograde introducers are in position, the case is completely heparinized to prevent any thrombus development throughout the interference process. An exchange dimension 0.018-inch wire was utilized to try passing across the disorder in a retrograde manner, it has very accurate outcomes crossing the obstruction for combination of a small sufficient diameter with adequate body support to permit crossing of the obstruction calcified in several patients. The V18 TM Control Wire Guide Wire is specifically beneficial at such condition. It has a hydrophilic tip which may assist in sliding via the blockade with mild frictions, and simultaneously the wire has sufficient stiffness to pass across the overall occlusion. In sometimes, the usage of the 0.018 system only aiming for crossing isn't sufficient. Such condition specifically develops when there are prolonged occlusions and when there is marked calcification. In such patients, additional reinforcement is required for the platform to permit the crossing. Thus, up-sizing to a 0.035 system might help in disorder crossing. When we pass through the disorder, an angiogram from below is conducted to prove the situation in the actual lumen beyond the disorder. The 0.018-inch system and wire were removed and hemostasis secured via digital compression for 8 minutes or by ante-grade balloon dilatation at the site of puncture for about 2-3 minutes.
Patient follow-up: Patients had been evaluated through the ABPI and duplex US examination: immediately, three mo., 6 mo., and 1 year following the surgery.
- Conditions
- Critical Lower Limb Ischemia
- Being tested
- Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb
- Keywords
- transpedal access, retrogradeangioplasty, critical limb ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limbProcedure or surgery
Briefly, conventional femoral access will be conducted in the traditional manner and involve the sheath while the catheter was introduced close to the proximal degree of lesion.
Access to a pedal vessel: Using a 21-guage needle or by utilizing a micro puncture access set. Such vessel is recognized using the US probe. such approach performed in 54 patients.a fluoroscopy might enable a good possibility for efficient access. In addition, it was suggested to utilize micro-puncture needle supposed to have echogenic pattern as the tip of regular needle is very hard to visualize utilizing the duplex US probe. Also, use of straight fluoroscopy or road mapping may offer a better chance for successful access, this method is done in 31 cases . Another method is open method (cut down) on tibial vessels, this method is done in 11 cases.
| Study group | Role | What they receive |
|---|---|---|
| transpedal access | Experimental | Trans-pedal Access for Endovascular Revascularization in patients with failed antegrade access forComplex Infra-popliteal Lesions in Critically Ischemic Limb Receives: Procedure: Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency
patency of the vessels after intervention
Measured: one year
amputation free survival rates
limb salvage after precedure
Measured: one year
30 days' mortality and morbidity.
major adverse effects related to procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Mar 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Lower Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436405
- Sponsor's protocol ID
- mansouravascular
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-pedal Access for Endovascular Revascularization in Complex Infra-popliteal Lesions in Critically Ischemic Limb
- ClinicalTrials.gov ID
- NCT05436405
- Acronym / sponsor ID
- mansouravascular
- Conditions
- Critical Lower Limb Ischemia
- Keywords
- transpedal access, retrogradeangioplasty, critical limb ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: critical limb ischemia is one of the most challenging cases we face nowadays with high risk for amputation, retrograde trans-pedal angioplasty offers an alternative technique after failure of traditional ante-grade angioplasty.
Patients and Methods: 96 patients underwent trans-pedal or trans-tibial retrograde angioplasty after failure of the traditional ante-grade angioplasty with the aid of US, 21-gauge needle and 0.018 wire through sheath-less approach as a last chance for revascularization
Detailed description
Study Design: This prospective non randomized study that had been performed at vascular surgery department at Mansoura University Hospital between March 2018 and April 2020, who was selected for 96patients undergoing endovascular BTK revascularization for CLI owing to tibial vascular diseases and gave written informed consent. Such cases who not give good response following traditional ante-grade ipsilateral trans-femoral approach and consequently underwent retrograde Trans-pedal or transtibial access to provide endovascular management for the lesions.
Inclusion criteria:
- all patients aged from (18-80) years, males and female
- patients with 1ry lesion (without previous trial of angioplasty or bypass)
- 2ry lesion (after previous trial of angioplasty or bypass),
- the patients with fountain classification (stage IIB, stage III, stage IV)
- patients with Rutherford classification (grade I "category 3", grade II, Category 4", grade III, Category 4\&category 5.
Exclusion criteria:
- patients with untreated osteomyelitis,
- patients with mixed lesions with other comorbidities (CVI \& Lymphoedema),
- patients with vasculitis or Buerger's dis.
- Also, who can't give consent (mentally retarded patients) or those with behavioral disorders .
Study tools History Data: included patient's demographics, underlying medical conditions, any previous surgery, transplanted kidney and other associated morbidity.
Examination: Full arterial assessments included pulse examination, and the ABPI (ankle brachial pressure index).
Laboratory: Blood picture, Blood sugar level, Kidney functions, Liver functions and Coagulation profile.
Imaging: Duplex ultra-sonographic (US) examination and CTA. Technique: Entire cases underwent full therapeutic medication prior to interference. Entire cases were tried ante-grade re-vascularization with a subsequent failure. A lower limb angiogram was be ready in entire cases prior to the retrograde procedure performance. Briefly, conventional femoral access will be conducted in the traditional manner and involve the sheath while the catheter was introduced close to the proximal degree of lesion.
Access to a pedal vessel: Using a 21-guage needle with insertion of 0.018-inch wire by sheathless technique (Figure 1) or by utilizing a micro puncture access set. A duplex-guided access has a great importance in terms of evaluation of the pedal as well as tibial blood vessels. Such vessel is recognized using the US probe. Color flow is utilized for identification of the objective artery flow, after that color disappeared while the needle is utilized for accessing the anterior vascular surface by utilizing duplex US , such approach performed in 54 patients. There are technical points worth mentioning utilizing such procedure: usage the smallest ready US as the major ones are bulky and may have a role in interference with the access process. In addition, marked vascular calcification may induce marked shadow making the identification very hard to be detected. In such conditions, a fluoroscopy might enable a good possibility for efficient access. In addition, it was suggested to utilize micro-puncture needle supposed to have echogenic pattern as the tip of regular needle is very hard to visualize utilizing the duplex US probe. Also, use of straight fluoroscopy or road mapping may offer a better chance for successful access, as we mentioned before, this method is done in 31 cases . Appropriate section of the actual place of vascular access is essential for the successfulness of such procedure. Generally, a patent vascular is selected to be the access situation. A micro-puncture needle is utilized for access. Occasionally, bending the needle tip has the ability to make the possibility of vascular evaluation easy which has great importance if the access point in the ATA beyond the ankle. Another method is open method (cut down) on tibial vessels, this method is done in 11 cases. Following evaluating the artery, established by back hemorrhage, the micro puncture access wire is introduced via the needle into the vessels underneath fluoroscopic guide in a retrograde fashion. The needle is removed and micro puncture set (4F) or the balloon itself is passed over the wire to secure the access. According to micro puncture introducer set it includes a 21- gauge, 7- cm echogenic needle, 10 - cm long micro puncture 4-french introducer and 2.9F inner caliber permitting passage of the equipment. When the retrograde introducers are in position, the case is completely heparinized to prevent any thrombus development throughout the interference process. An exchange dimension 0.018-inch wire was utilized to try passing across the disorder in a retrograde manner, it has very accurate outcomes crossing the obstruction for combination of a small sufficient diameter with adequate body support to permit crossing of the obstruction calcified in several patients. The V18 TM Control Wire Guide Wire is specifically beneficial at such condition. It has a hydrophilic tip which may assist in sliding via the blockade with mild frictions, and simultaneously the wire has sufficient stiffness to pass across the overall occlusion. In sometimes, the usage of the 0.018 system only aiming for crossing isn't sufficient. Such condition specifically develops when there are prolonged occlusions and when there is marked calcification. In such patients, additional reinforcement is required for the platform to permit the crossing. Thus, up-sizing to a 0.035 system might help in disorder crossing. When we pass through the disorder, an angiogram from below is conducted to prove the situation in the actual lumen beyond the disorder. The 0.018-inch system and wire were removed and hemostasis secured via digital compression for 8 minutes or by ante-grade balloon dilatation at the site of puncture for about 2-3 minutes.
Patient follow-up: Patients had been evaluated through the ABPI and duplex US examination: immediately, three mo., 6 mo., and 1 year following the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transpedal access | Experimental | Procedure: Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limbTrans-pedal Access for Endovascular Revascularization in patients with failed antegrade access forComplex Infra-popliteal Lesions in Critically Ischemic Limb |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- all patients aged from (18-80) years, males and female
- patients with 1ry lesion (without previous trial of angioplasty or bypass)
- 2ry lesion (after previous trial of angioplasty or bypass),
- the patients with fountain classification (stage IIB, stage III, stage IV)
- patients with Rutherford classification (grade I "category 3", grade II, Category 4", grade III, Category 4\&category 5.
Key exclusion criteria (4 listed)
- patients with untreated osteomyelitis,
- patients with mixed lesions with other comorbidities (CVI \& Lymphoedema),
- patients with vasculitis or Buerger's dis.
- Also, who can't give consent (mentally retarded patients) or those with behavioral disorders .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limbBriefly, conventional femoral access will be conducted in the traditional manner and involve the sheath while the catheter was introduced close to the proximal degree of lesion. Access to a pedal vessel: Using a 21-guage needle or by utilizing a micro puncture access set. Such vessel is recognized using the US probe. such approach performed in 54 patients.a fluoroscopy might enable a good possibility for efficient access. In addition, it was suggested to utilize micro-puncture needle supposed to have echogenic pattern as the tip of regular needle is very hard to visualize utilizing the duplex US probe. Also, use of straight fluoroscopy or road mapping may offer a better chance for successful access, this method is done in 31 cases . Another method is open method (cut down) on tibial vessels, this method is done in 11 cases. | Procedure or surgery | transpedal access |
Primary outcome
primary patency
Time frame: one year
patency of the vessels after intervention
amputation free survival rates
Time frame: one year
limb salvage after precedure
30 days' mortality and morbidity.
Time frame: 30 days
major adverse effects related to procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb in people with Critical Lower Limb Ischemia, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary patency (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.