Trial Outcomes & Findings for Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery (NCT NCT02085551)

NCT ID: NCT02085551

Last Updated: 2020-06-22

Results Overview

Proportion of patients with a post-procedure TIMI score of 2 to 3.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 85 participants
• Primary outcome timeframe: Immediate post-procedure
• Results posted on: 2020-06-22

Participant Flow

Participant milestones

Measure	Mechanical Thrombectomy by the Indigo System Mechanical Thrombectomy by the Indigo System
Overall Study STARTED	85
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

Baseline characteristics by cohort

Measure	Mechanical Thrombectomy by the Indigo System n=85 Participants Mechanical Thrombectomy by the Indigo System
Age, Continuous	68.5 Years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Region of Enrollment United States	85 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediate post-procedure

Population: TIMI score at immediate post-procedure was unavailable for one patient.

Proportion of patients with a post-procedure TIMI score of 2 to 3.

Outcome measures

Measure	Mechanical Thrombectomy by the Indigo System n=84 Participants Mechanical Thrombectomy by the Indigo System
Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores	74 Participants

PRIMARY outcome

Timeframe: During the procedure

Outcome measures

Measure	Mechanical Thrombectomy by the Indigo System n=85 Participants Mechanical Thrombectomy by the Indigo System
Procedural Serious Adverse Events	5 Participants

Adverse Events

Mechanical Thrombectomy by the Indigo System

Serious events: 15 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mechanical Thrombectomy by the Indigo System n=85 participants at risk Mechanical Thrombectomy by the Indigo System
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.2% 1/85 • up to 24 hours after procedure.
Blood and lymphatic system disorders Anaemia	8.2% 7/85 • up to 24 hours after procedure.
Gastrointestinal disorders Abdominal Compartment Syndrome	1.2% 1/85 • up to 24 hours after procedure.
Gastrointestinal disorders Intestinal Ischaemia	1.2% 1/85 • up to 24 hours after procedure.
Surgical and medical procedures Leg Amputation	2.4% 2/85 • up to 24 hours after procedure.
Musculoskeletal and connective tissue disorders Myocardial Infarction	1.2% 1/85 • up to 24 hours after procedure.
Cardiac disorders Pulseless Electrical Activity	1.2% 1/85 • up to 24 hours after procedure.
Renal and urinary disorders Renal Failure	1.2% 1/85 • up to 24 hours after procedure.
Vascular disorders Shock	1.2% 1/85 • up to 24 hours after procedure.
Immune system disorders Systemic Inflammatory Response Syndrome	1.2% 1/85 • up to 24 hours after procedure.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm Ruptured	1.2% 1/85 • up to 24 hours after procedure.
Vascular disorders Vessel Puncture Site Haematoma	1.2% 1/85 • up to 24 hours after procedure.

Other adverse events

Measure	Mechanical Thrombectomy by the Indigo System n=85 participants at risk Mechanical Thrombectomy by the Indigo System
Surgical and medical procedures Leg Amputation	2.4% 2/85 • up to 24 hours after procedure.
Gastrointestinal disorders Abdominal Compartment Syndrome	1.2% 1/85 • up to 24 hours after procedure.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.2% 1/85 • up to 24 hours after procedure.
Blood and lymphatic system disorders Anaemia	8.2% 7/85 • up to 24 hours after procedure.
Infections and infestations Clostridium Difficule Colitis	1.2% 1/85 • up to 24 hours after procedure.
Vascular disorders Embolism	5.9% 5/85 • up to 24 hours after procedure.
Vascular disorders Epistaxis	1.2% 1/85 • up to 24 hours after procedure.
Skin and subcutaneous tissue disorders Erythema	1.2% 1/85 • up to 24 hours after procedure.
Metabolism and nutrition disorders Fluid Overload	1.2% 1/85 • up to 24 hours after procedure.
Gastrointestinal disorders Gastrointestinal Haemorrhage	1.2% 1/85 • up to 24 hours after procedure.
Gastrointestinal disorders Haematemesis	1.2% 1/85 • up to 24 hours after procedure.
Reproductive system and breast disorders Haematuria	1.2% 1/85 • up to 24 hours after procedure.
Vascular disorders Haemorrhage	1.2% 1/85 • up to 24 hours after procedure.
General disorders Heparin-Induced Thrombocytopenia	1.2% 1/85 • up to 24 hours after procedure.
Vascular disorders Hypotension	1.2% 1/85 • up to 24 hours after procedure.
Gastrointestinal disorders Intestinal Ischaemia	1.2% 1/85 • up to 24 hours after procedure.
Psychiatric disorders Mental Status Changes	1.2% 1/85 • up to 24 hours after procedure.
Cardiac disorders Myocardial Infarction	1.2% 1/85 • up to 24 hours after procedure.
Cardiac disorders Pulseless Electrical Activity	1.2% 1/85 • up to 24 hours after procedure.
Renal and urinary disorders Renal Failure	1.2% 1/85 • up to 24 hours after procedure.
Renal and urinary disorders Renal Failure Acute	2.4% 2/85 • up to 24 hours after procedure.
Cardiac disorders Shock	1.2% 1/85 • up to 24 hours after procedure.
Immune system disorders Systemic Inflammatory Response Syndrome	1.2% 1/85 • up to 24 hours after procedure.
Infections and infestations Upper Respiratory Tract Infection	1.2% 1/85 • up to 24 hours after procedure.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm Ruptured	1.2% 1/85 • up to 24 hours after procedure.
Vascular disorders Vasospasm	7.1% 6/85 • up to 24 hours after procedure.
Vascular disorders Vessel Puncture Site Haematoma	1.2% 1/85 • up to 24 hours after procedure.
Eye disorders Visual Impairment	1.2% 1/85 • up to 24 hours after procedure.

Additional Information

Michaella Corso

Penumbra, Inc.

Phone: +1 510-995-2079

Email: mcorso@penumbrainc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place