Trial Outcomes & Findings for ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial (NCT NCT00759681)

NCT ID: NCT00759681

Last Updated: 2013-01-31

Results Overview

The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 217 participants
• Primary outcome timeframe: Immediate at time of surgery
• Results posted on: 2013-01-31

Participant Flow

A total of 217 subjects (110 ArterX, 107 Control) were treated at eleven (11) participating investigational centers. Randomized subjects were treated from 10/08 to 12/09. The last follow-up visit was conducted in 03/10.

Participant milestones

Measure	Control: Gelfoam and Thrombin Gelfoam PlusTM is used to seal suture lines of arterial grafts or patches made from PTFE and Dacron. Gelfoam is a sterile compressed sponge and Thrombin is the last enzyme in the clotting cascade.	Investigational Device: ArterX Surgical Sealant ArterX is a two-component sealant provided in a double barreled syringe. The main components are bovine serum albumin and a polyaldehyde formed from polymerized glutaraldehyde. The solutions are dispensed through a double plunger, mixing the two components in a 1:1 ratio by passing them through a specially designed mixing tip, delivering up to 2 ml volume of each component.
Overall Study STARTED	107	110
Overall Study COMPLETED	97	100
Overall Study NOT COMPLETED	10	10

Reasons for withdrawal

Measure	Control: Gelfoam and Thrombin Gelfoam PlusTM is used to seal suture lines of arterial grafts or patches made from PTFE and Dacron. Gelfoam is a sterile compressed sponge and Thrombin is the last enzyme in the clotting cascade.	Investigational Device: ArterX Surgical Sealant ArterX is a two-component sealant provided in a double barreled syringe. The main components are bovine serum albumin and a polyaldehyde formed from polymerized glutaraldehyde. The solutions are dispensed through a double plunger, mixing the two components in a 1:1 ratio by passing them through a specially designed mixing tip, delivering up to 2 ml volume of each component.
Overall Study Death	2	5
Overall Study Lost to Follow-up	8	5

Baseline Characteristics

ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Baseline characteristics by cohort

Measure	Control n=107 Participants Control Treatment: Gelfoam and Thrombin	Investigational Device n=110 Participants Investigational Treatment: ArterX Surgical Sealant	Total n=217 Participants Total of all reporting groups
Age Continuous	65.7 years STANDARD_DEVIATION 12.3 • n=5 Participants	66.2 years STANDARD_DEVIATION 12.3 • n=7 Participants	66.0 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	41 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Region of Enrollment United States	107 participants n=5 Participants	110 participants n=7 Participants	217 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediate at time of surgery

Population: Treatment sites were the unit of measure based on ITT for effectiveness outcomes.

The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery

Outcome measures

Measure	Control Treatment n=164 Treatment sites Control Treatment: Gelfoam and Thrombin	Investigational Device n=167 Treatment sites Investigational Device: ArterX Surgical Sealant
Immediate Sealing Evidenced by no Bleeding on Clamp Release.	65 Treatment sites	101 Treatment sites

PRIMARY outcome

Timeframe: Treatment through 6 weeks

Population: Based on ITT population for primary safety analysis.

The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.

Outcome measures

Measure	Control Treatment n=107 Participants Control Treatment: Gelfoam and Thrombin	Investigational Device n=110 Participants Investigational Device: ArterX Surgical Sealant
Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response	64 participants	51 participants

Adverse Events

2. Gelfoam and Thrombin

Serious events: 26 serious events

Other events: 11 other events

Deaths: 0 deaths

1. ArterX Surgical Sealant

Serious events: 28 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	2. Gelfoam and Thrombin n=106 participants at risk；n=107 participants at risk Gelfoam and Thrombin	1. ArterX Surgical Sealant n=108 participants at risk；n=110 participants at risk ArterX Surgical Sealant
Surgical and medical procedures Significant Bleeding	1.9% 2/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	2.7% 3/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Infections and infestations Infection	17.9% 19/106 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	8.3% 9/108 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Nervous system disorders Neurological Deficit	1.9% 2/105 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	2.8% 3/108 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Immune system disorders Immune/Inflammatory Allergic Response	0.00% 0/106 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	0.00% 0/108 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Investigations Death	1.9% 2/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	4.5% 5/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Vascular disorders Hypotension	0.00% 0/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	2.7% 3/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Vascular disorders Thrombosis/Thromboembolism	0.93% 1/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	2.7% 3/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Vascular disorders Ischemia	0.93% 1/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	1.8% 2/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Respiratory, thoracic and mediastinal disorders Respiratory Failure/Dysfunction	1.9% 2/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	2.7% 3/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Vascular disorders Steal Syndrome	0.00% 0/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	1.8% 2/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Cardiac disorders Myocardial Infarction	0.00% 0/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	0.91% 1/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.93% 1/107 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	0.00% 0/110 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.

Other adverse events

Measure	2. Gelfoam and Thrombin n=106 participants at risk；n=107 participants at risk Gelfoam and Thrombin	1. ArterX Surgical Sealant n=108 participants at risk；n=110 participants at risk ArterX Surgical Sealant
Infections and infestations Non-serious Infections	10.4% 11/106 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.	8.3% 9/108 • Adverse events were collected through 3 months post surgery. Adverse events were collected from surgery through hospital discharge, and at each follow-up visit, 6 weeks and 3 months post-surgery.

Additional Information

David Cull, MD

Greenville Memorial Hospital

Phone: 864-455-9825

Results disclosure agreements

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