Trial Outcomes & Findings for Chronic Total Occlusion Crossing With the Wildcat Catheter (NCT NCT01174784)

NCT ID: NCT01174784

Last Updated: 2020-07-17

Results Overview

The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 88 participants
• Primary outcome timeframe: Index through 30-Day Follow-Up
• Results posted on: 2020-07-17

Participant Flow

Subjects were recruited/enrolled in the study starting on August 31, 2010. 88 subjects were enrolled and exited the study by April 11, 2011. Angiographic review after the case revealed that 4 of the 88 cases did not meet the inclusion criteria and were considered screen failures per the protocol and excluded from the efficacy analyses.

Participant milestones

Measure	Device Treatment This is a one-arm study. All subjects will have a CTO addressed by the Wildcat crossing device.
Overall Study STARTED	88
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Device Treatment This is a one-arm study. All subjects will have a CTO addressed by the Wildcat crossing device.
Overall Study Screen fails	4

Baseline Characteristics

Chronic Total Occlusion Crossing With the Wildcat Catheter

Baseline characteristics by cohort

Measure	Enrolled/Primary Cohort n=88 Participants Subjects with a CTO upon presentation to the surgical unit.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=93 Participants
Age, Categorical >=65 years	62 Participants n=93 Participants
Age, Continuous	69.5 years STANDARD_DEVIATION 11.1 • n=93 Participants
Sex: Female, Male Female	41 Participants n=93 Participants
Sex: Female, Male Male	47 Participants n=93 Participants
Region of Enrollment United States	88 participants n=93 Participants

PRIMARY outcome

Timeframe: Index through 30-Day Follow-Up

Population: Patients treated with Wildcat post guidewire failure.

The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.

Outcome measures

Measure	Enrolled/Primary Cohort n=84 Participants Patients with 99% to 100% stenosis of a peripheral artery were approached to join the study.
Major Adverse Events	4 participants

PRIMARY outcome

Timeframe: Index through 30-Day Follow-Up

Population: Patients treated with Wildcat post guidewire failure.

Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.

Outcome measures

Measure	Enrolled/Primary Cohort n=84 Participants Patients with 99% to 100% stenosis of a peripheral artery were approached to join the study.
CTO Crossing Success Using the Wildcat	75 participants

Adverse Events

Enrolled/Primary Cohort

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Enrolled/Primary Cohort n=84 participants at risk Patient with 99% to 100% stenosis of a peripheral artery.
General disorders Major Adverse Event - Death	0.00% 0/84 • 30-Days
Vascular disorders Major Adverse Event - Unplanned Major Amputation	0.00% 0/84 • 30-Days
Vascular disorders Major Adverse Event - Emergent Target Vessel Revascularization	0.00% 0/84 • 30-Days
Vascular disorders Clinically Significant Perforation	4.8% 4/84 • Number of events 4 • 30-Days
Vascular disorders Clinically Significant Embolization	0.00% 0/84 • 30-Days
Vascular disorders Grade C Dissection	0.00% 0/84 • 30-Days

Other adverse events

Adverse event data not reported

Additional Information

Thomas Lawson, PhD

Avinger Inc.

Phone: 650.241.7900

Email: tlawson@avinger.com

Results disclosure agreements

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

Restriction type: LTE60