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Clinical Trials/ISRCTN14469736
ISRCTN14469736
Active, not recruiting
未知

Multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting stents and plain balloon angioplasty with bail-out bare metal stent revascularisation strategies for severe limb ischaemia due to atherosclerotic femoro-popliteal, with or without infra-popliteal involvement, peripheral arterial disease

niversity of Birmingham0 sites481 target enrollmentOctober 22, 2015
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ConditionsSevere limb ischaemia due to femoro-popliteal diseaseCirculatory SystemPeripheral vascular disease, unspecified

Overview

Phase
未知
Intervention
Not specified
Conditions
Severe limb ischaemia due to femoro-popliteal disease
Sponsor
niversity of Birmingham
Enrollment
481
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28526046 protocol

Registry
who.int
Start Date
October 22, 2015
End Date
August 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 18 years or over
  • •2\. Have severe limb ischaemia due to femoro\-popliteal, with or without infra\-popliteal, peripheral artery disease
  • •3\. Be judged by the responsible clinicians (consultant vascular surgeon, interventional radiologist, diabetologist) working as part of a multidisciplinary team to require early endovascular femoro\-popliteal, with or without infra\-popliteal revascularisation in addition to best medical treatment, foot and wound care
  • •4\. Have adequate ‘inflow’ to support all possible trial revascularisation strategies
  • •5\. Be judged suitable for all possible trial revascularisation strategies following diagnostic imaging and a formal (documented) discussion by a multi\-disciplinary team meeting

Exclusion Criteria

  • •1\. Have an anticipated life expectancy \<6 months
  • •2\. Are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity \[Scotland] Act 2000\)
  • •3\. Are a non\-English speaker where translation facilities are insufficient to guarantee informed consent
  • •4\. Are judged unsuitable for any of the revascularisation strategies being evaluated

Outcomes

Primary Outcomes

Not specified

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