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Trans-pedal Access for Endovascular Revascularization in Complex Infra-popliteal Lesions in Critically Ischemic Limb

25 de junho de 2022 atualizado por: Mansoura University

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

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

96

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Mansoura, Egito, 35615
        • Mansoura University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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 .

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: transpedal access
Trans-pedal Access for Endovascular Revascularization in patients with failed antegrade access forComplex Infra-popliteal Lesions in Critically Ischemic Limb

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
primary patency
Prazo: one year
patency of the vessels after intervention
one year
amputation free survival rates
Prazo: one year
limb salvage after precedure
one year
30 days' mortality and morbidity.
Prazo: 30 days
major adverse effects related to procedure
30 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2018

Conclusão Primária (Real)

1 de abril de 2020

Conclusão do estudo (Real)

1 de abril de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

15 de junho de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de junho de 2022

Primeira postagem (Real)

29 de junho de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de junho de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de junho de 2022

Última verificação

1 de junho de 2022

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • mansouravascular

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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