Trial Outcomes & Findings for Complete Lesion Assessment With ffR and IVUS TechnologY (NCT NCT01941030)
NCT ID: NCT01941030
Last Updated: 2023-07-18
Results Overview
The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Post-balloon angioplasty
Results posted on
2023-07-18
Participant Flow
Participant milestones
| Measure |
Orbital Atherectomy System
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
Orbital Atherectomy System
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
Baseline Characteristics
Complete Lesion Assessment With ffR and IVUS TechnologY
Baseline characteristics by cohort
| Measure |
Orbital Atherectomy System
n=25 Participants
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA) Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA) Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 Participants
Balloon Angioplasty (BA) alone Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Number of treated lesions
|
26 lesions
n=5 Participants
|
26 lesions
n=7 Participants
|
52 lesions
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-balloon angioplastyPopulation: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.
The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.
Outcome measures
| Measure |
Orbital Atherectomy System
n=26 lesions
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 lesions
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS
|
25.0 percentage of lumen gain
Interval 11.1 to 42.9
|
0.0 percentage of lumen gain
Interval 0.0 to 6.7
|
PRIMARY outcome
Timeframe: Pre-intervention, and post-balloon angioplastyPopulation: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.
The pre- (Pre-Tx) and post-treatment (Post-Tx) minimum lumen area percent stenosis. A positive value equates to a decrease in lumen area percent stenosis.
Outcome measures
| Measure |
Orbital Atherectomy System
n=26 lesions
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 lesions
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS
Pre-Tx, minimum area stenosis (%)
|
43.8 percent of minimum area stenosis
Interval 37.6 to 62.4
|
45.2 percent of minimum area stenosis
Interval 34.5 to 58.5
|
|
Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS
Post-Tx, minimum area stenosis (%)
|
36.4 percent of minimum area stenosis
Interval 29.0 to 51.5
|
31.5 percent of minimum area stenosis
Interval 26.5 to 45.2
|
PRIMARY outcome
Timeframe: Pre-intervention, and post-balloon angioplastyPopulation: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.
The pre- (Pre-Tx) and post-treatment (Post-Tx) plaque area. A positive value equates to a decrease in plaque area.
Outcome measures
| Measure |
Orbital Atherectomy System
n=26 lesions
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 lesions
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Change in Plaque Area as Assessed by IVUS
Pre-Tx, plaque area (mm^3/mm)
|
6.5 area (mm^3/mm)
Interval 4.7 to 8.2
|
6.0 area (mm^3/mm)
Interval 4.9 to 6.5
|
|
Change in Plaque Area as Assessed by IVUS
Post-Tx, plaque area (mm^3/mm)
|
6.3 area (mm^3/mm)
Interval 4.4 to 10.0
|
6.0 area (mm^3/mm)
Interval 5.6 to 7.1
|
PRIMARY outcome
Timeframe: Pre-intervention, and post-balloon angioplastyPopulation: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.
The pre- (Pre-Tx) and post-treatment (Post-Tx) dense calcium area. A positive value equates to a decrease in dense calcium area.
Outcome measures
| Measure |
Orbital Atherectomy System
n=26 lesions
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 lesions
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Change in Dense Calcium Area as Assessed by IVUS
Pre-Tx, dense calcium area (mm^3/mm)
|
0.7 area (mm^3/mm)
Interval 0.2 to 1.5
|
1.0 area (mm^3/mm)
Interval 0.2 to 1.4
|
|
Change in Dense Calcium Area as Assessed by IVUS
Post-Tx, dense calcium area (mm^3/mm)
|
0.4 area (mm^3/mm)
Interval 0.2 to 1.2
|
1.1 area (mm^3/mm)
Interval 0.2 to 1.7
|
PRIMARY outcome
Timeframe: Pre-intervention, and post-balloon angioplastyPopulation: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.
The pre- (Pre-Tx) and post-treatment (Post-Tx) necrotic core area. A positive value equates to a decrease necrotic core area.
Outcome measures
| Measure |
Orbital Atherectomy System
n=26 lesions
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 lesions
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Change in Necrotic Core Area as Assessed by IVUS
Pre-Tx, necrotic core area (mm^3/mm)
|
0.7 area (mm^3/mm)
Interval 0.4 to 1.2
|
0.9 area (mm^3/mm)
Interval 0.4 to 1.2
|
|
Change in Necrotic Core Area as Assessed by IVUS
Post-Tx, necrotic core area (mm^3/mm)
|
0.8 area (mm^3/mm)
Interval 0.3 to 1.0
|
1.0 area (mm^3/mm)
Interval 0.5 to 1.1
|
PRIMARY outcome
Timeframe: Pre-intervention, and post-balloon angioplastyPopulation: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrous plaque area. A positive value equates to a decrease in fibrous plaque area.
Outcome measures
| Measure |
Orbital Atherectomy System
n=26 lesions
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 lesions
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Change in Fibrous Plaque Area as Assessed by IVUS
Pre-Tx, fibrous plaque area (mm^3/mm)
|
1.7 area (mm^3/mm)
Interval 0.9 to 2.6
|
1.0 area (mm^3/mm)
Interval 0.6 to 2.0
|
|
Change in Fibrous Plaque Area as Assessed by IVUS
Post-Tx, fibrous plaque area (mm^3/mm)
|
1.4 area (mm^3/mm)
Interval 0.9 to 3.3
|
0.9 area (mm^3/mm)
Interval 0.8 to 1.6
|
PRIMARY outcome
Timeframe: Pre-intervention, and post-balloon angioplastyPopulation: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrofatty plaque area. A positive value equates to a decrease in fibrofatty plaque area.
Outcome measures
| Measure |
Orbital Atherectomy System
n=26 lesions
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 lesions
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Change in Fibrofatty Plaque Area as Assessed by IVUS
Pre-Tx, fibrofatty plaque area (mm^3/mm)
|
0.2 area (mm^3/mm)
Interval 0.1 to 0.7
|
0.1 area (mm^3/mm)
Interval 0.0 to 0.3
|
|
Change in Fibrofatty Plaque Area as Assessed by IVUS
Post-Tx, fibrofatty plaque area (mm^3/mm)
|
0.2 area (mm^3/mm)
Interval 0.1 to 1.0
|
0.1 area (mm^3/mm)
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)Population: Some sites were exempt from performing FFR. Not all subjects had available FFR.
Fractional flow reserve (FFR) will be measured to assess hemodynamic function following each device procedure. During FFR, adenosine will be given through the femoral artery sheath or access catheter in two doses: 600 mcg and 1200 mcg. A higher FFR is presumed to correlate to better flow which may improve wound healing.
Outcome measures
| Measure |
Orbital Atherectomy System
n=26 lesions
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 lesions
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Fractional Flow Reserve
Post final OAS: FFR w/ 600 mcg adenosine
|
0.83 Ratio (proximal/distal pressure)
Standard Deviation 0.14
|
NA Ratio (proximal/distal pressure)
Standard Deviation NA
Post final OAS value provided. OAS not used in Balloon Angioplasty arm.
|
|
Fractional Flow Reserve
Post final OAS: FFR with 1200 mcg adenosine
|
0.80 Ratio (proximal/distal pressure)
Standard Deviation 0.12
|
NA Ratio (proximal/distal pressure)
Standard Deviation NA
Post final OAS value provided. OAS not used in Balloon Angioplasty arm.
|
|
Fractional Flow Reserve
Post final balloon: FFR w/ 600 mcg adenosine
|
0.90 Ratio (proximal/distal pressure)
Standard Deviation 0.13
|
0.75 Ratio (proximal/distal pressure)
Standard Deviation 0.22
|
|
Fractional Flow Reserve
Post final balloon: FFR w/ 1200 mcg adenosine
|
0.87 Ratio (proximal/distal pressure)
Standard Deviation 0.10
|
0.76 Ratio (proximal/distal pressure)
Standard Deviation 0.24
|
Adverse Events
Orbital Atherectomy System
Serious events: 22 serious events
Other events: 4 other events
Deaths: 3 deaths
Balloon Angioplasty
Serious events: 17 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Orbital Atherectomy System
n=25 participants at risk
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 participants at risk
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Cellulitis, index limb
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Cardiac disorders
Congestive Heart Failure
|
8.0%
2/25 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 3 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Cardiac disorders
Coronary Artery disease, worsening
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Vascular disorders
Deep Vein Thrombosis, upper arm
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Cardiac disorders
Death, cardiac
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
General disorders
Death, non-cardiac
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
General disorders
Death, unknown cause
|
8.0%
2/25 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Injury, poisoning and procedural complications
Dissection
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Injury, poisoning and procedural complications
Distal embolization
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Gastrointestinal disorders
GI bleeding
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Infections and infestations
Infection, other
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Major amputation, index limb, due to infected knee replacement
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Major amputation, index limb due to gangrene
|
8.0%
2/25 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Major amputation, index limb due to osteomyelitis
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
General disorders
Medication overdose
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
General disorders
Medication side effect
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Minor amputation - pre-planned, index limb
|
8.0%
2/25 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
15.4%
4/26 • Number of events 4 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Minor amputation, index limb due to gangrene
|
8.0%
2/25 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Minor amputation, index limb due to osteomyelitis
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Minor amputation, non-index limb due to gangrene
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Minor amputation, non-index limb due to osteomyelitis
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Infections and infestations
Osteomyelitis, index limb
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Infections and infestations
Osteomyelitis, non-index limb
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
General disorders
Other - Syncope
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Injury, poisoning and procedural complications
Recoil
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
11.5%
3/26 • Number of events 3 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.0%
2/25 • Number of events 2 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Revascularization - pre-planned, non-index limb
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Revascularization, index limb (non-TVR)
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
11.5%
3/26 • Number of events 5 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Revascularization, index limb (TLR)
|
12.0%
3/25 • Number of events 3 • AEs were collected during the index-procedure through 12 months of follow-up.
|
11.5%
3/26 • Number of events 3 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Surgical and medical procedures
Revascularization, non-index limb
|
16.0%
4/25 • Number of events 4 • AEs were collected during the index-procedure through 12 months of follow-up.
|
7.7%
2/26 • Number of events 6 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Renal and urinary disorders
Urinary retention
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Vascular disorders
Worsening of index wound
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
Other adverse events
| Measure |
Orbital Atherectomy System
n=25 participants at risk
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Orbital Atherectomy System: Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
Balloon Angioplasty
n=26 participants at risk
Balloon Angioplasty (BA) alone
Balloon Angioplasty: Type of balloon selected is driven by preference of the operator.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Access site bleeding
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Injury, poisoning and procedural complications
Dissection
|
4.0%
1/25 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
19.2%
5/26 • Number of events 5 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
General disorders
Lower extremity edema
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm, access site
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Injury, poisoning and procedural complications
Slow flow
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/25 • AEs were collected during the index-procedure through 12 months of follow-up.
|
3.8%
1/26 • Number of events 1 • AEs were collected during the index-procedure through 12 months of follow-up.
|
|
Injury, poisoning and procedural complications
Vessel spasm
|
12.0%
3/25 • Number of events 3 • AEs were collected during the index-procedure through 12 months of follow-up.
|
0.00%
0/26 • AEs were collected during the index-procedure through 12 months of follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60