The Indigo System in Acute Lower Limb Malperfusion (INDIAN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03386370|
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemia of Lower Limb||Device: "Indigo" Mechanical Thrombectomy System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||May 2019|
Treatment by "Indigo" mechanical thrombectomy system
Acute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo
Device: "Indigo" Mechanical Thrombectomy System
Removal of acute clot (< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra
- Technical success of the thromboaspiration with the Indigo system. [ Time Frame: At intra-procedural completion angiography ]The primary endpoint of the study is the technical success of the thromboaspiration with the Indigo system. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications both before and after use of the device.
- Clinical success at 1 month follow-up. [ Time Frame: 1 month ]Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
- Safety Rate at discharge: Serious adverse event. [ Time Frame: 1 month ]Safety rate at discharge, defined as absence of any serious adverse events (SAE). A SAE is defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability.
- Primary Patency [ Time Frame: 1 month ]Primary patency at 1 month. Primary patency is defined as a target lesion without a hemodynamically significant stenosis/reocclusion on duplex ultrasound (>50%,) and without target lesion reintervention (TLR) within 1 month.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386370
|Contact: Gianmarco de Donato, MDemail@example.com|
|Contact: Carlo Setacci, MDfirstname.lastname@example.org|
|Vascular Surgery, University of Siena||Recruiting|
|Siena, Italy, 53100|
|Contact: Gianmarco de Donato, MD|
|Principal Investigator: Carlo Setacci, MD|
|Principal Investigator: Gianmarco de Donato, MD|