Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System

NCT03295539 | Unknown DMC FDA Device

• 1 other identifier: Indigo2017
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

International Multi-Centre registry recording comprehensive data on the use of 'Indigo' Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or critical limb ischaemia.

Conditions

Lower Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Technical success using the Indigo system.

  Intraoperative technical success defined as the restoration of antegrade blood flow with complete or near complete (95% by volume) removal of the thrombus or embolus (70% threshold). This is assessed using imaging modalities (USS/Doppler/Fluroscopy) and clinical assessment of the affected limb. See for this definition the enclosed citation. In conclusion, the primary outcome measure will be improvement in blood flow across a lesion assessed by the improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures.Target lesions were grouped anatomically into above-the-knee(ATK) or below-the-knee(BTK) lesions.

  Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.

Study Arms (1)

Acute or Chronic clot

OTHER

If chronic clot, no intervention given via Indigo

Device: 'Indigo' Mechanical thrombectomy system

Interventions

'Indigo' Mechanical thrombectomy system DEVICE

Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO"

Acute or Chronic clot

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute lower limb Ischaemia with acute soft clot.

You may not qualify if:

• Calcified plaques/ chronic disease causing critical limb Ischaemia

Sponsors & Collaborators

• Lancashire Care NHS Foundation Trust: lead
• St. Franziskus Hospital: collaborator

Study Sites (1)

Interventional Radiology

Preston, Lancashire, PR2 7HR, United Kingdom

Location

Related Publications (1)

• Karnabatidis D, Spiliopoulos S, Tsetis D, Siablis D. Quality improvement guidelines for percutaneous catheter-directed intra-arterial thrombolysis and mechanical thrombectomy for acute lower-limb ischemia. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1123-36. doi: 10.1007/s00270-011-0258-z. Epub 2011 Sep 1.

  PMID: 21882081 RESULT

Study Officials

• Bella Huasen, MD

  Lancashire NHS

  STUDY CHAIR

Central Study Contacts

Bella Huasen, MD

CONTACT

00447871800565; doctorbella.h@gmail.com

Theo Bisdas, Phd, MD

CONTACT

00492519355829; th.bisdas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endovascular Interventional Consultant

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 28, 2017
• Study Start: November 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: while the study is on-going
• Access Criteria: Centres taking part will be given the access via the three main trial investigators Dr Huasen, Dr Bisdas, and Dr Beropoulis

Locations

GB (1)