Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan

Acute Limb Ischemia Clinical Trial

— JapanIndigoPMS  

Official title:

Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446024
• Other study ID #: 27548
• Status: Recruiting
• Start date: December 7, 2023
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: Penumbra Inc.
• Contact: Mikiharu Morita
• Phone: +1-510-440-5612
• Email: mmorita[@]penumbrainc.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.

Exclusion Criteria:

Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.

Related Conditions & MeSH terms

• Acute DVT of Lower Extremity
• Acute Limb Ischemia
• Arterial Occlusion Mesenteric Artery Superior
• Arterial Occlusive Diseases

Intervention

Device:
• Mechanical aspiration thrombectomy
Mechanical thrombectomy is an endovascular technique for removing blood clots from vessels. Penumbra's Indigo system actively extracts thrombus using a continuous vacuum pump, enabling aspiration of thrombus of various sizes and lengths.

Locations

Country	Name	City	State
United States	Sponsor Penumbra, Inc.	Alameda	California

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALI: Target Limb Salvage	Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle)	30 days post-treatment and 6 months post-treatment
Primary	ALI: Technical Success	Primary technical success should be defined per vessel treated on an intent-to-treat basis and applies only to segment treated with Indigo. Defined as successful use of the device to re-establish any antegrade flow and complete or near complete (95% by volume) removal of thrombus as assessed by visual analysis of angiographic images or by other objective imaging such as DUS, CTA, or MRA.	Intraoperative
Primary	ALI: Major device-related bleeding in ALI patients	Major bleeding events as defined by ISTH	Periprocedural
Primary	SMA: Technical success	Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.	Intraoperative
Primary	SMA: Device-related Distal Embolization	A distal filling defect with an abrupt cut-off, determined to be new since the pre-procedure angiogram, present at the end of the procedure, and clinically significant requiring intervention other than Indigo use. If the area in question was not clearly visualized, filling defects distal to the target lesion cannot be categorized as emboli.	Intraoperative
Primary	DVT: Technical success	Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography	Intraoperative
Primary	DVT: Major Device-Related Bleeding	Major device-related bleeding as defined by ISTH	Periprocedural
Primary	DVT: New Symptomatic Pulmonary Embolism (PE)	Symptomatic new PE objectively confirmed on Computed Tomographic Pulmonary Angiography (CTPA), echocardiography, MRI, or invasive contrast pulmonary angiography.	30 days post-treatment
Primary	DVT: Clinically significant re-thrombosis of the target venous segment	Re-thrombosis of target vein segment requiring re-intervention within 30 days	30 days post-treatment
Primary	All Disease States: Device-related Serious adverse effects (SAE) and mortality	Device related SAE and all-cause mortality	6 months post-treatment