Trial Outcomes & Findings for Registry of AngioJet Use in the Peripheral Vascular System (NCT NCT01086215)
NCT ID: NCT01086215
Last Updated: 2014-11-10
Results Overview
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, 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/venographic value from the final value.
Recruitment status
COMPLETED
Target enrollment
500 participants
Primary outcome timeframe
Day 1
Results posted on
2014-11-10
Participant Flow
Patients presenting at a participating site who were clinically indicated for a peripheral interventional (arterial, venous or hemodialysis access) procedure with the AngioJet Thrombectomy System were offered the opportuntity to participate. Patients were recruited from January 2010 thru June 2013.
Participant milestones
| Measure |
Limb Ischemia
Patients presenting with limb ischemia for treatment
|
Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
|
Hemodialysis Access
Patients presenting with thrombosed hemodialysis access for treatment
|
Other Thrombotic Conditions
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
212
|
201
|
73
|
14
|
|
Overall Study
3 Month Follow Up
|
201
|
187
|
64
|
13
|
|
Overall Study
6 Month Follow Up
|
192
|
172
|
60
|
12
|
|
Overall Study
12 Month Follow Up
|
176
|
154
|
47
|
11
|
|
Overall Study
COMPLETED
|
176
|
154
|
47
|
11
|
|
Overall Study
NOT COMPLETED
|
36
|
47
|
26
|
3
|
Reasons for withdrawal
| Measure |
Limb Ischemia
Patients presenting with limb ischemia for treatment
|
Deep Vein Thrombosis
Patients presenting with deep vein thrombosis for treatment
|
Hemodialysis Access
Patients presenting with thrombosed hemodialysis access for treatment
|
Other Thrombotic Conditions
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
|
|---|---|---|---|---|
|
Overall Study
Death
|
14
|
8
|
8
|
1
|
|
Overall Study
Lost to Follow-up
|
22
|
39
|
18
|
2
|
Baseline Characteristics
Registry of AngioJet Use in the Peripheral Vascular System
Baseline characteristics by cohort
| Measure |
Limb Ischemia
n=212 Participants
Patients presenting with limb ischemia for treatment
|
Deep Vein Thrombosis
n=201 Participants
Patients presenting with deep vein thrombosis for treatment
|
Hemodialysis Access
n=73 Participants
Patients presenting with thrombosed hemodialysis access for treatment
|
Other Thrombotic Conditions
n=14 Participants
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 11.59 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 16.37 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 13.94 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 12.07 • n=4 Participants
|
58.1 years
STANDARD_DEVIATION 15.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
292 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=5 Participants
|
190 participants
n=7 Participants
|
73 participants
n=5 Participants
|
13 participants
n=4 Participants
|
430 participants
n=21 Participants
|
|
Region of Enrollment
Slovakia
|
54 participants
n=5 Participants
|
11 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Intention to Treat (ITT)
From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, 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/venographic value from the final value.
Outcome measures
| Measure |
Limb Ischemia
n=212 Participants
Patients presenting with limb ischemia for treatment
|
Deep Vein Thrombosis
n=201 Participants
Patients presenting with deep vein thrombosis for treatment
|
Hemodialysis Access
n=73 Participants
Patients presenting with thrombosed hemodialysis access for treatment
|
Other Thrombotic Conditions
n=14 Participants
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
|
|---|---|---|---|---|
|
Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.
Baseline Value
|
1.31 Units on a Scale
Standard Error 0.03
|
1.33 Units on a Scale
Standard Error 0.03
|
1.36 Units on a Scale
Standard Error 0.06
|
1.80 Units on a Scale
Standard Error 0.16
|
|
Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.
Final Value
|
3.76 Units on a Scale
Standard Error 0.04
|
3.73 Units on a Scale
Standard Error 0.03
|
3.87 Units on a Scale
Standard Error 0.04
|
3.75 Units on a Scale
Standard Error 0.12
|
|
Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.
Levels of Change
|
2.45 Units on a Scale
Standard Error 0.05
|
2.40 Units on a Scale
Standard Error 0.04
|
2.50 Units on a Scale
Standard Error 0.07
|
1.95 Units on a Scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: 3 Month , 6 Month and 12 Month Follow UpThe number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.
Outcome measures
| Measure |
Limb Ischemia
n=212 Participants
Patients presenting with limb ischemia for treatment
|
Deep Vein Thrombosis
n=201 Participants
Patients presenting with deep vein thrombosis for treatment
|
Hemodialysis Access
n=73 Participants
Patients presenting with thrombosed hemodialysis access for treatment
|
Other Thrombotic Conditions
n=14 Participants
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
|
|---|---|---|---|---|
|
Rethrombosis
3 Month Follow Up
|
21 participants
|
22 participants
|
15 participants
|
0 participants
|
|
Rethrombosis
6 Month Follow Up
|
9 participants
|
4 participants
|
12 participants
|
0 participants
|
|
Rethrombosis
12 Month Follow Up
|
9 participants
|
3 participants
|
7 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure
Outcome measures
| Measure |
Limb Ischemia
n=212 Participants
Patients presenting with limb ischemia for treatment
|
Deep Vein Thrombosis
n=201 Participants
Patients presenting with deep vein thrombosis for treatment
|
Hemodialysis Access
n=73 Participants
Patients presenting with thrombosed hemodialysis access for treatment
|
Other Thrombotic Conditions
n=14 Participants
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
|
|---|---|---|---|---|
|
Concomitant Treatments Used With the AngioJet® System
AngioJet Thrombectomy + Lytic Delivery
|
146 participants
|
175 participants
|
15 participants
|
9 participants
|
|
Concomitant Treatments Used With the AngioJet® System
Non AngioJet Thrombectomy
|
31 participants
|
14 participants
|
45 participants
|
2 participants
|
|
Concomitant Treatments Used With the AngioJet® System
AngioJet Thrombectomy without Lytic
|
102 participants
|
94 participants
|
67 participants
|
6 participants
|
|
Concomitant Treatments Used With the AngioJet® System
Balloon Angioplasty
|
164 participants
|
157 participants
|
69 participants
|
6 participants
|
|
Concomitant Treatments Used With the AngioJet® System
Stent Placement
|
124 participants
|
71 participants
|
29 participants
|
2 participants
|
|
Concomitant Treatments Used With the AngioJet® System
Catheter Directed Thrombolysis
|
106 participants
|
143 participants
|
0 participants
|
2 participants
|
|
Concomitant Treatments Used With the AngioJet® System
Atherectomy
|
9 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Concomitant Treatments Used With the AngioJet® System
Filter Placement
|
17 participants
|
51 participants
|
0 participants
|
0 participants
|
Adverse Events
Limb Ischemia
Serious events: 2 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=212 participants at risk
Patients presenting with limb ischemia for treatment
|
Deep Vein Thrombosis
n=201 participants at risk
Patients presenting with deep vein thrombosis for treatment
|
Hemodialysis Access
n=73 participants at risk
Patients presenting with thrombosed hemodialysis access for treatment
|
Other Thrombotic Conditions
n=14 participants at risk
Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
|
|---|---|---|---|---|
|
Surgical and medical procedures
Bleeding Requiring Transfusion
|
0.94%
2/212 • Index Procedure thru 12 Month Follow Up
Events that were related to the initial Index Procedure and/or AngioJet
|
0.50%
1/201 • Index Procedure thru 12 Month Follow Up
Events that were related to the initial Index Procedure and/or AngioJet
|
0.00%
0/73 • Index Procedure thru 12 Month Follow Up
Events that were related to the initial Index Procedure and/or AngioJet
|
0.00%
0/14 • Index Procedure thru 12 Month Follow Up
Events that were related to the initial Index Procedure and/or AngioJet
|
|
Renal and urinary disorders
Renal Failure
|
0.47%
1/212 • Index Procedure thru 12 Month Follow Up
Events that were related to the initial Index Procedure and/or AngioJet
|
0.50%
1/201 • Index Procedure thru 12 Month Follow Up
Events that were related to the initial Index Procedure and/or AngioJet
|
0.00%
0/73 • Index Procedure thru 12 Month Follow Up
Events that were related to the initial Index Procedure and/or AngioJet
|
0.00%
0/14 • Index Procedure thru 12 Month Follow Up
Events that were related to the 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: LTE60