Trial Outcomes & Findings for Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II (NCT NCT01537302)
NCT ID: NCT01537302
Last Updated: 2021-03-22
Results Overview
No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Day 30
Results posted on
2021-03-22
Participant Flow
Patients with CTO were approached to consider joining the study.
Participant milestones
| Measure |
Ocelot System
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data unknown for 12 subjects.
Baseline characteristics by cohort
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 9.3 • n=100 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
64 Participants
n=88 Participants • Data unknown for 12 subjects.
|
|
Race/Ethnicity, Customized
African American
|
18 Participants
n=88 Participants • Data unknown for 12 subjects.
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
3 Participants
n=88 Participants • Data unknown for 12 subjects.
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=88 Participants • Data unknown for 12 subjects.
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=88 Participants • Data unknown for 12 subjects.
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=88 Participants • Data unknown for 12 subjects.
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=88 Participants • Data unknown for 12 subjects.
|
|
Region of Enrollment
United States
|
81 participants
n=100 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=100 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=100 Participants
|
|
Rutherford
0 - Asymptomatic
|
0 Participants
n=100 Participants
|
|
Rutherford
1 - Mild Claudication
|
0 Participants
n=100 Participants
|
|
Rutherford
2 - Moderate Claudication
|
13 Participants
n=100 Participants
|
|
Rutherford
3 - Severe Claudication
|
61 Participants
n=100 Participants
|
|
Rutherford
4 - Ischemic Rest Pain
|
20 Participants
n=100 Participants
|
|
Rutherford
5 - Minor Tissue Loss
|
6 Participants
n=100 Participants
|
|
Rutherford
6 - Major Tissue Loss
|
0 Participants
n=100 Participants
|
|
Ankle-Brachial Index
ABI >1.3: Non-Compressible Vessels
|
0 Participants
n=98 Participants • Data not obtained for 2 subjects.
|
|
Ankle-Brachial Index
ABI ≥ 0.95: Normal
|
5 Participants
n=98 Participants • Data not obtained for 2 subjects.
|
|
Ankle-Brachial Index
ABI < 0.95: Peripheral Vascular Disease
|
47 Participants
n=98 Participants • Data not obtained for 2 subjects.
|
|
Ankle-Brachial Index
ABI < 0.6: Intermittent Claudication
|
38 Participants
n=98 Participants • Data not obtained for 2 subjects.
|
|
Ankle-Brachial Index
ABI < 0.4: Chronic Limb Ischemia
|
8 Participants
n=98 Participants • Data not obtained for 2 subjects.
|
|
Body Mass Index
|
28.7 kg/m^2
STANDARD_DEVIATION 6.1 • n=100 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Two subjects withdrew prior to 30-day follow-up.
No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.
Outcome measures
| Measure |
Ocelot System
n=98 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Primary Safety Endpoint
|
2 Percent of participants
Interval to 6.0
This is a 95% one-sided confidence interval.
|
PRIMARY outcome
Timeframe: Day 0Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Primary Efficacy Endpoint
|
97 Participants
|
SECONDARY outcome
Timeframe: Day 0Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections.
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Procedural Success
|
95 Participants
|
SECONDARY outcome
Timeframe: Day 0Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Technical Success
|
72 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: 'Catheter Performance Evaluation: Tip Deflection': Data was missing for one subject for this question. 'OCT Performance Evaluation: Visualization of side branches': N/A in 9 subjects who did not have side branches visualized.
Device performance as assessed by Investigator's input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO.
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Device Performance
Catheter Performance Evaluation: Introduction into sheath · 5 - Excellent
|
87 Participants
|
|
Device Performance
Catheter Performance Evaluation: Introduction into sheath · 4 - Good
|
13 Participants
|
|
Device Performance
Catheter Performance Evaluation: Introduction into sheath · 3 - Acceptable
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Introduction into sheath · 2 - Poor
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Introduction into sheath · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter trackability · 5 - Excellent
|
76 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter trackability · 4 - Good
|
21 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter trackability · 3 - Acceptable
|
3 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter trackability · 2 - Poor
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter trackability · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter pushability · 5 - Excellent
|
62 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter pushability · 4 - Good
|
31 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter pushability · 3 - Acceptable
|
6 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter pushability · 2 - Poor
|
1 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter pushability · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Tip Deflection · 5 - Excellent
|
56 Participants
|
|
Device Performance
Catheter Performance Evaluation: Tip Deflection · 4 - Good
|
25 Participants
|
|
Device Performance
Catheter Performance Evaluation: Tip Deflection · 3 - Acceptable
|
18 Participants
|
|
Device Performance
Catheter Performance Evaluation: Tip Deflection · 2 - Poor
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Tip Deflection · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Ability to stay in true lumen · 5 - Excellent
|
65 Participants
|
|
Device Performance
Catheter Performance Evaluation: Ability to stay in true lumen · 4 - Good
|
22 Participants
|
|
Device Performance
Catheter Performance Evaluation: Ability to stay in true lumen · 3 - Acceptable
|
10 Participants
|
|
Device Performance
Catheter Performance Evaluation: Ability to stay in true lumen · 2 - Poor
|
2 Participants
|
|
Device Performance
Catheter Performance Evaluation: Ability to stay in true lumen · 1 - Unacceptable
|
1 Participants
|
|
Device Performance
Catheter Performance Evaluation: Visibility of radiopaque marker · 5 - Excellent
|
82 Participants
|
|
Device Performance
Catheter Performance Evaluation: Visibility of radiopaque marker · 4 - Good
|
13 Participants
|
|
Device Performance
Catheter Performance Evaluation: Visibility of radiopaque marker · 3 - Acceptable
|
5 Participants
|
|
Device Performance
Catheter Performance Evaluation: Visibility of radiopaque marker · 2 - Poor
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Visibility of radiopaque marker · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter tip visibility · 5 - Excellent
|
84 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter tip visibility · 4 - Good
|
13 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter tip visibility · 3 - Acceptable
|
3 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter tip visibility · 2 - Poor
|
0 Participants
|
|
Device Performance
Catheter Performance Evaluation: Catheter tip visibility · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
OCT Performance Evaluation: Clarity of images · 5 - Excellent
|
63 Participants
|
|
Device Performance
OCT Performance Evaluation: Clarity of images · 4 - Good
|
31 Participants
|
|
Device Performance
OCT Performance Evaluation: Clarity of images · 3 - Acceptable
|
5 Participants
|
|
Device Performance
OCT Performance Evaluation: Clarity of images · 2 - Poor
|
0 Participants
|
|
Device Performance
OCT Performance Evaluation: Clarity of images · 1 - Unacceptable
|
1 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of layered structures · 5 - Excellent
|
65 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of layered structures · 4 - Good
|
22 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of layered structures · 3 - Acceptable
|
11 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of layered structures · 2 - Poor
|
1 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of layered structures · 1 - Unacceptable
|
1 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of non-layered structures · 5 - Excellent
|
63 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of non-layered structures · 4 - Good
|
20 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of non-layered structures · 3 - Acceptable
|
14 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of non-layered structures · 2 - Poor
|
2 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of non-layered structures · 1 - Unacceptable
|
1 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of side branches · 5 - Excellent
|
60 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of side branches · 4 - Good
|
24 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of side branches · 3 - Acceptable
|
7 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of side branches · 2 - Poor
|
0 Participants
|
|
Device Performance
OCT Performance Evaluation: Visualization of side branches · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
OCT Performance Evaluation: Flush adequately displaces blood for visualization · 5 - Excellent
|
70 Participants
|
|
Device Performance
OCT Performance Evaluation: Flush adequately displaces blood for visualization · 4 - Good
|
28 Participants
|
|
Device Performance
OCT Performance Evaluation: Flush adequately displaces blood for visualization · 3 - Acceptable
|
2 Participants
|
|
Device Performance
OCT Performance Evaluation: Flush adequately displaces blood for visualization · 2 - Poor
|
0 Participants
|
|
Device Performance
OCT Performance Evaluation: Flush adequately displaces blood for visualization · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability to orient using the middle marker · 5 - Excellent
|
65 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability to orient using the middle marker · 4 - Good
|
25 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability to orient using the middle marker · 3 - Acceptable
|
10 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability to orient using the middle marker · 2 - Poor
|
0 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability to orient using the middle marker · 1 - Unacceptable
|
0 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation · 5 - Excellent
|
70 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation · 4 - Good
|
22 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation · 3 - Acceptable
|
7 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation · 2 - Poor
|
1 Participants
|
|
Device Performance
OCT Performance Evaluation: Ability of OCT marker band to aid in catheter navigation · 1 - Unacceptable
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Procedural Time
|
107.3 minutes
Standard Deviation 57.5
|
SECONDARY outcome
Timeframe: Day 0Total time fluoroscopy was used during the procedure.
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Fluoroscopic Time
|
38.6 minutes
Standard Deviation 29.1
|
SECONDARY outcome
Timeframe: Day 0Time required to cross the CTO during the procedure.
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
CTO Crossing Time
|
32.9 minutes
Standard Deviation 42.9
|
SECONDARY outcome
Timeframe: Day 0Population: Seventy-two participants in the 'CTO Crossing Time: Ocelot Alone'. Twenty-five participants in the 'CTO Crossing Time: Ocelot and assist devices'. Three subjects who did not have their CTO successfully crossed were excluded from calculation.
Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices.
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Use of Assist Devices
CTO Crossing Time: Ocelot Alone
|
16.8 minutes
Standard Deviation 18.4
|
|
Use of Assist Devices
CTO Crossing Time: Ocelot and assist devices
|
79.1 minutes
Standard Deviation 58.1
|
SECONDARY outcome
Timeframe: Day 0Contrast and flush volumes are presented
Outcome measures
| Measure |
Ocelot System
n=100 Participants
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Contrast/Flush Volumes
Contrast Volume (used for entire procedure)
|
223.0 ml
Standard Deviation 144.7
|
|
Contrast/Flush Volumes
Flush Volume (through Ocelot for visualization only)
|
33.1 ml
Standard Deviation 57.9
|
|
Contrast/Flush Volumes
Contrast Volume (procedure start through CTO crossing)
|
124.5 ml
Standard Deviation 100.3
|
Adverse Events
Ocelot System
Serious events: 26 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ocelot System
n=100 participants at risk
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Injury, poisoning and procedural complications
AV Fistula
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Injury, poisoning and procedural complications
Vessel Dissection, Grade C or greater
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Injury, poisoning and procedural complications
Vessel Dissection, Grade A or B
|
3.0%
3/100 • Number of events 3 • Day 0 through Day 30
|
|
Vascular disorders
Bruising or hemorrhage at procedural access site
|
3.0%
3/100 • Number of events 4 • Day 0 through Day 30
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
2/100 • Number of events 3 • Day 0 through Day 30
|
|
Vascular disorders
Thrombosis
|
3.0%
3/100 • Number of events 3 • Day 0 through Day 30
|
|
Vascular disorders
Pain, new or worsening
|
3.0%
3/100 • Number of events 3 • Day 0 through Day 30
|
|
Infections and infestations
Infection
|
3.0%
3/100 • Number of events 3 • Day 0 through Day 30
|
|
Vascular disorders
Pseudoaneurysm
|
3.0%
3/100 • Number of events 3 • Day 0 through Day 30
|
|
Vascular disorders
Bleeding (other than access site)
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Vascular disorders
Hypotension, sustained
|
3.0%
3/100 • Number of events 3 • Day 0 through Day 30
|
|
Injury, poisoning and procedural complications
Perforation requiring intervention
|
3.0%
3/100 • Number of events 3 • Day 0 through Day 30
|
|
Cardiac disorders
Shortness of breath
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Renal and urinary disorders
Urinary tract infection
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Injury, poisoning and procedural complications
Perforation, not requiring intervention
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Acute COPD exacerbation
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Vascular disorders
limb ischemia
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Vascular disorders
Aneurysm
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Vascular disorders
Embolism
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Immune system disorders
Allergic reaction to contrast medium
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Psychiatric disorders
Altered mental state
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Vascular disorders
Leg ulcerations
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Gastrointestinal disorders
Intractable nausea/vomiting
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
General disorders
Lethargy
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Metabolism and nutrition disorders
Uncontrolled hyperglycemia
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
Other adverse events
| Measure |
Ocelot System
n=100 participants at risk
CTO crossing in femoropopliteal arteries using the Ocelot System
|
|---|---|
|
Vascular disorders
Bruising or hemorrhage at procedural access site
|
9.0%
9/100 • Number of events 9 • Day 0 through Day 30
|
|
Vascular disorders
Swelling
|
5.0%
5/100 • Number of events 5 • Day 0 through Day 30
|
|
Vascular disorders
Bleeding, other than access site
|
2.0%
2/100 • Number of events 2 • Day 0 through Day 30
|
|
Psychiatric disorders
Confusion
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Nervous system disorders
Dysphagia
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
General disorders
Nausea/Vomiting
|
4.0%
4/100 • Number of events 4 • Day 0 through Day 30
|
|
General disorders
Pain, new or worsening
|
3.0%
3/100 • Number of events 3 • Day 0 through Day 30
|
|
Injury, poisoning and procedural complications
Perforation not requiring intervention
|
2.0%
2/100 • Number of events 2 • Day 0 through Day 30
|
|
Vascular disorders
Pseudoaneurysm
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Vascular disorders
Vessel dissection, Grade A or B
|
5.0%
5/100 • Number of events 5 • Day 0 through Day 30
|
|
Vascular disorders
Vessel dissection, Grade C or greater
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
|
Vascular disorders
AV fistula
|
1.0%
1/100 • Number of events 1 • Day 0 through Day 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the earliest of (a)publication of results, (b)receipt of notice stating that Study has been terminated or (c)18 months after completion or termination, Institution/Investigator (IN) shall have right to publish information \& data collected or produced, provided that drafts are provided to Sponsor (SP) at least 60 days prior to the first submission. SP shall comment within 45 days. IN shall delay publication/presentation to enable SP to secure patent or other proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER