Trial Outcomes & Findings for A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters (NCT NCT00778336)
NCT ID: NCT00778336
Last Updated: 2014-10-17
Results Overview
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,each vessel was assigned a value by the treating physician: 1. complete occlusion (\> 90% occlusion); 2. substantial occlusion (50-90% occlusion OR \<50% occlusion and \>3cm in length); 3. partial occlusion (\<50% occlusion AND \<3cm in length); 4. patent (Without visable thrombus or occlusion). The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value.
Recruitment status
COMPLETED
Target enrollment
452 participants
Primary outcome timeframe
Index Procedure ( pre-endovascular treatment and post-endovascular treatment)
Results posted on
2014-10-17
Participant Flow
Patients presenting at a participating site who were clinically indicated for a peripheral interventional(venous or arterial) procedure with the mid-length (90cm or 120cm catheters) catheter were offered the opportunity to participate. Patients were recruited from January 2007 thru December 2009.
Participant milestones
| Measure |
Limb Ischemia
Patients with limb ischemia treated with a midlength AngioJet catheter.
|
Deep Vein Thrombosis
Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
|
Hemodialysis Access
Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
|
Other Thrombotic Conditions
Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
|
|---|---|---|---|---|
|
Index Procedure-Discharge
STARTED
|
198
|
170
|
72
|
12
|
|
Index Procedure-Discharge
COMPLETED
|
192
|
167
|
70
|
12
|
|
Index Procedure-Discharge
NOT COMPLETED
|
6
|
3
|
2
|
0
|
|
3 Month Follow Up
STARTED
|
192
|
167
|
70
|
12
|
|
3 Month Follow Up
COMPLETED
|
169
|
144
|
65
|
12
|
|
3 Month Follow Up
NOT COMPLETED
|
23
|
23
|
5
|
0
|
Reasons for withdrawal
| Measure |
Limb Ischemia
Patients with limb ischemia treated with a midlength AngioJet catheter.
|
Deep Vein Thrombosis
Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
|
Hemodialysis Access
Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
|
Other Thrombotic Conditions
Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
|
|---|---|---|---|---|
|
Index Procedure-Discharge
Death
|
6
|
3
|
2
|
0
|
|
3 Month Follow Up
Lost to Follow-up
|
15
|
20
|
3
|
0
|
|
3 Month Follow Up
Death
|
8
|
3
|
2
|
0
|
Baseline Characteristics
A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
Baseline characteristics by cohort
| Measure |
Limb Ischemia
n=198 Participants
Patients with limb ischemia treated with a midlength AngioJet catheter.
|
Deep Vein Thrombosis
n=170 Participants
Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
|
Hemodialysis Access
n=72 Participants
Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
|
Other Thrombotic Conditions
n=12 Participants
Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 14 • n=99 Participants
|
52 years
STANDARD_DEVIATION 17 • n=107 Participants
|
63 years
STANDARD_DEVIATION 13 • n=206 Participants
|
63 years
STANDARD_DEVIATION 18 • n=7 Participants
|
61 years
STANDARD_DEVIATION 16 • n=31 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
192 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
260 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=99 Participants
|
170 participants
n=107 Participants
|
72 participants
n=206 Participants
|
12 participants
n=7 Participants
|
452 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Index Procedure ( pre-endovascular treatment and post-endovascular treatment)Population: Intention to Treat (ITT)
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,each vessel was assigned a value by the treating physician: 1. complete occlusion (\> 90% occlusion); 2. substantial occlusion (50-90% occlusion OR \<50% occlusion and \>3cm in length); 3. partial occlusion (\<50% occlusion AND \<3cm in length); 4. patent (Without visable thrombus or occlusion). The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value.
Outcome measures
| Measure |
Limb Ischemia
n=198 Participants
Patients treated with a midlength Angiojet catheter for limb ischemia
|
Deep Vein Thrombosis
n=170 Participants
Patients treated with a midlength Angiojet catheter for deep vein thrombosis
|
Hemodialysis Access
n=72 Participants
Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
|
Other Thrombotic Conditions
n=12 Participants
Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
|
|---|---|---|---|---|
|
Change From Baseline to Final Angiographic Results
Baseline (pre-treatment) Angiograph Value
|
1.32 Occlusion Index
Standard Error 0.04
|
1.37 Occlusion Index
Standard Error 0.04
|
1.16 Occlusion Index
Standard Error 0.05
|
1.89 Occlusion Index
Standard Error 0.14
|
|
Change From Baseline to Final Angiographic Results
Final (post-treatment) Angiograph Value
|
3.67 Occlusion Index
Standard Error 0.05
|
3.67 Occlusion Index
Standard Error 0.04
|
3.80 Occlusion Index
Standard Error 0.07
|
3.54 Occlusion Index
Standard Error 0.14
|
|
Change From Baseline to Final Angiographic Results
Levels of Change (baseline minus final values)
|
2.36 Occlusion Index
Standard Error 0.06
|
2.30 Occlusion Index
Standard Error 0.05
|
2.63 Occlusion Index
Standard Error 0.08
|
1.63 Occlusion Index
Standard Error 0.18
|
SECONDARY outcome
Timeframe: 3 Month Follow UpThe number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).
Outcome measures
| Measure |
Limb Ischemia
n=198 Participants
Patients treated with a midlength Angiojet catheter for limb ischemia
|
Deep Vein Thrombosis
n=170 Participants
Patients treated with a midlength Angiojet catheter for deep vein thrombosis
|
Hemodialysis Access
n=72 Participants
Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
|
Other Thrombotic Conditions
n=12 Participants
Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
|
|---|---|---|---|---|
|
Rethrombosis
|
17 Participants
|
11 Participants
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Index ProcedureThe # of patients that were exposed to each treatment at least once in the given thrombotic condition.
Outcome measures
| Measure |
Limb Ischemia
n=198 Participants
Patients treated with a midlength Angiojet catheter for limb ischemia
|
Deep Vein Thrombosis
n=170 Participants
Patients treated with a midlength Angiojet catheter for deep vein thrombosis
|
Hemodialysis Access
n=72 Participants
Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
|
Other Thrombotic Conditions
n=12 Participants
Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
|
|---|---|---|---|---|
|
Description of Treatments by Thrombotic Condition
Catheter Directed Thrombolysis
|
76 Participants
|
79 Participants
|
1 Participants
|
3 Participants
|
|
Description of Treatments by Thrombotic Condition
AngioJet Thrombectomy without Lytic
|
70 Participants
|
78 Participants
|
68 Participants
|
6 Participants
|
|
Description of Treatments by Thrombotic Condition
AngioJet Thrombectomy + Lytic Delivery
|
121 Participants
|
144 Participants
|
4 Participants
|
8 Participants
|
|
Description of Treatments by Thrombotic Condition
Balloon Angioplasty
|
144 Participants
|
120 Participants
|
59 Participants
|
4 Participants
|
|
Description of Treatments by Thrombotic Condition
Stent Placement
|
96 Participants
|
48 Participants
|
30 Participants
|
3 Participants
|
|
Description of Treatments by Thrombotic Condition
Atherectomy
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Description of Treatments by Thrombotic Condition
Filter Placement
|
8 Participants
|
34 Participants
|
0 Participants
|
6 Participants
|
|
Description of Treatments by Thrombotic Condition
Non AngioJet Thrombectomy
|
11 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
Limb Ischemia
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Deep Vein Thrombosis
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Hemodialysis Access
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Other Thrombotic Conditions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Limb Ischemia
n=198 participants at risk
Patients with limb ischemia treated with a midlength AngioJet catheter.
|
Deep Vein Thrombosis
n=170 participants at risk
Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
|
Hemodialysis Access
n=72 participants at risk
Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
|
Other Thrombotic Conditions
n=12 participants at risk
Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Bleeding Requiring transfusion
|
2.0%
4/198 • Number of events 4 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/170 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/72 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/12 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
|
Renal and urinary disorders
Renal Failure
|
1.0%
2/198 • Number of events 2 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/170 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/72 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/12 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
|
Endocrine disorders
Pancreatitis
|
0.51%
1/198 • Number of events 1 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/170 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/72 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/12 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
0.00%
0/198 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.59%
1/170 • Number of events 1 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/72 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/12 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
|
Renal and urinary disorders
Elevated Creatinine
|
0.00%
0/198 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.59%
1/170 • Number of events 1 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/72 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
0.00%
0/12 • Index procedure thru Discharge, 3 Month Follow Up
Events that were related to initial index procedure and/or AngioJet.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60