Multidisciplinary therapeutic and active follow-up protocols to reduce the rate of amputations and cardiovascular morbidities in patients with critical limb ischemia: IRANCLI study design and rationale – A prospective single-center registry in Iran

• Main Authors: Omid Shafe, Jamal Moosavi, Seifollah Abdi, Hosein Ali Basiri, Hamidreza Pouraliakbar, Ali Setayesh, Sara Yasini Ardakani, Saman Alilou, Shirin Rafatnia, Hooman Bakhshandeh, Farhad Jalili, Parham Sadeghipour
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2019-01-01
• Series: Research in Cardiovascular Medicine
• Subjects: Amputation; critical limb ischemia; peripheral artery disease; revascularization; toe-brachial index
• Online Access: http://www.rcvmonline.com/article.asp?issn=2251-9572;year=2019;volume=8;issue=2;spage=46;epage=53;aulast=Shafe

Objectives: The endovascular treatment (EVT) of patients with critical limb ischemia (CLI) has received considerable interest in recent years and has significantly affected the associated amputation and survival rates. Nonetheless, that this management modality may be influenced by various logistical and regional situations prompted us to design a local registry to evaluate its applicability and efficacy in our community.Methods: The IRANCLI study is a prospective, observational study that has been established as a registry. The therapeutic and follow-up protocols of this study have been approved by a multidisciplinary team. Recruited patients with CLI are followed up after in-hospital therapeutic management, endovascular revascularization, or minor amputations or debridement in cases with ulcers. The follow-up consists of active monitoring to spot patients with a recurrence of CLI signs and symptoms at early stages. Within 3 years, eligible patients are recruited to the study and are followed up for 3 years. Analyses are carried out to evaluate outcomes – comprising major adverse limb events (the primary outcome), amputation-free survival, limb salvage, event-free survival, major adverse cardiovascular and cerebrovascular events, 30 days' postprocedural adverse events, and procedural success. The predictors of procedural failure and long-term follow-up adverse events are assessed. Result and Conclusion: The IRANCLI study evaluates postendovascular revascularization outcomes and the long-term follow-up of patients with CLI. Uncovering the predictors of EVT failure and adverse events during the follow-up may improve the prospect of cases with CLI by streamlining the determination of both the patients who would benefit the most from EVT and those who would need a closer active follow-up.