Trial Outcomes & Findings for Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging (NCT NCT02807779)
NCT ID: NCT02807779
Last Updated: 2025-07-17
Results Overview
The change in percent wall volume (PWV) of the treated segment between the postoperative and 12 month time points as measured by MRI
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
From Post-Operative Day One to 12 Months
Results posted on
2025-07-17
Participant Flow
Of 33 enrolled participants, 20 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Dexamethasone
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
1
|
|
Overall Study
COMPLETED
|
6
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dexamethasone
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
|
Overall Study
Death
|
1
|
1
|
0
|
Baseline Characteristics
Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging
Baseline characteristics by cohort
| Measure |
Dexamethasone
n=10 Participants
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=9 Participants
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
n=1 Participants
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
76 years
STANDARD_DEVIATION 0 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Hypertension
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Hyperlipidemia
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Diabetes mellitus
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Coronary artery disease
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Rutherford category
Rutherford category 1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Rutherford category
Rutherford category 2
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Rutherford category
Rutherford category 3
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Rutherford category
Rutherford category 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Rutherford category
Rutherford category 5
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
White blood cell count
|
8.6 10^9 cells/L
STANDARD_DEVIATION 1.8 • n=5 Participants
|
7.9 10^9 cells/L
STANDARD_DEVIATION 2.2 • n=7 Participants
|
8 10^9 cells/L
STANDARD_DEVIATION 0 • n=5 Participants
|
8.2 10^9 cells/L
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Hemoglobin
|
12.3 g/dL
STANDARD_DEVIATION 1.6 • n=5 Participants
|
12.9 g/dL
STANDARD_DEVIATION 1.1 • n=7 Participants
|
14.6 g/dL
STANDARD_DEVIATION 0 • n=5 Participants
|
12.7 g/dL
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
Hematocrit
|
37.5 percentage of hematocrit
STANDARD_DEVIATION 4.8 • n=5 Participants
|
38.8 percentage of hematocrit
STANDARD_DEVIATION 3.2 • n=7 Participants
|
43.2 percentage of hematocrit
STANDARD_DEVIATION 0 • n=5 Participants
|
38.4 percentage of hematocrit
STANDARD_DEVIATION 4.1 • n=4 Participants
|
|
Platelet count
|
225.1 10^9 platelets/L
STANDARD_DEVIATION 62.3 • n=5 Participants
|
244.5 10^9 platelets/L
STANDARD_DEVIATION 62.9 • n=7 Participants
|
157 10^9 platelets/L
STANDARD_DEVIATION 0 • n=5 Participants
|
229.9 10^9 platelets/L
STANDARD_DEVIATION 62.3 • n=4 Participants
|
|
C-Reactive Protein (CRP)
|
3.5 mg/L
n=5 Participants
|
2.0 mg/L
n=7 Participants
|
.33 mg/L
n=5 Participants
|
2.1 mg/L
n=4 Participants
|
|
Monocyte Chemotactic Protein 1 (MCP-1)
|
72.6 pg/mL
STANDARD_DEVIATION 21.5 • n=5 Participants
|
77.1 pg/mL
STANDARD_DEVIATION 19.6 • n=7 Participants
|
62.0 pg/mL
STANDARD_DEVIATION 0 • n=5 Participants
|
73.9 pg/mL
STANDARD_DEVIATION 19.8 • n=4 Participants
|
|
Interleukin 1 Beta (IL-1beta)
|
0.19 pg/mL
n=5 Participants
|
0.17 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0.19 pg/mL
n=4 Participants
|
PRIMARY outcome
Timeframe: From Post-Operative Day One to 12 MonthsPopulation: No data was collected for the Plain Balloon Angioplasty group
The change in percent wall volume (PWV) of the treated segment between the postoperative and 12 month time points as measured by MRI
Outcome measures
| Measure |
Dexamethasone
n=5 Participants
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=4 Participants
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Change in Percent Wall Volume (PWV)
|
12.3 Percent Wall Volume
Standard Deviation 11.6
|
3.9 Percent Wall Volume
Standard Deviation 4.3
|
—
|
SECONDARY outcome
Timeframe: From Post-Operative Day One to 12 MonthsPopulation: No data was collected for the Plain Balloon Angioplasty group
The change in wall volume (WV) without change in total vessel volume (TVV) of the treated segment between the postoperative and 12 month time points as measured by MRI
Outcome measures
| Measure |
Dexamethasone
n=5 Participants
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=4 Participants
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Change in Wall Volume (WV) Without a Change in Total Vessel Volume (TVV)
|
28.7 mm*3
Standard Deviation 78.5
|
4.5 mm*3
Standard Deviation 66.6
|
—
|
SECONDARY outcome
Timeframe: From Post-Operative Day One to 12 MonthsPopulation: No data was collected for the Plain Balloon Angioplasty group
The serum concentration of monocyte chemoattractant protein-1 (MCP-1) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the MCP-1 concentration (postprocedure day 1, 1 month and 12 months)
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=4 Participants
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Change in Perioperative Inflammatory Profile (MCP-1)
|
27933 pg*d/mL
Standard Deviation 3267
|
277745 pg*d/mL
Standard Deviation 4000
|
—
|
SECONDARY outcome
Timeframe: From Post-Operative Day One to 12 MonthsPopulation: No data was collected for the Plain Balloon Angioplasty group
The serum concentration of C-reactive protein (CRP) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the CRP concentration (postprocedure day 1, 1 month and 12 months).
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=4 Participants
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Change in Perioperative Inflammatory Profile (CRP)
|
1721 mg*d/L
Standard Deviation 1171
|
1863 mg*d/L
Standard Deviation 1475
|
—
|
SECONDARY outcome
Timeframe: From Post-Operative Day One to 12 MonthsPopulation: No subject had measurable serum IL-1beta at the 12month timepoint
The serum concentration of interleukin-1beta (IL-1beta) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the IL-1beta concentration (postprocedure day 1, 1 month and 12 months).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 1 Month to 6 MonthsPopulation: No data was collected for the Plain Balloon Angioplasty group
The change in adventitial transfer constant (Ktrans) of the treated segment between the postoperative and 6 month time points as measured by dynamic contrast enhanced MRI
Outcome measures
| Measure |
Dexamethasone
n=6 Participants
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=4 Participants
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Change in Transfer Constant (Ktrans)
|
-0.0002 min^-1
Standard Deviation 0.003
|
-0.0067 min^-1
Standard Deviation 0.006
|
—
|
SECONDARY outcome
Timeframe: From Post-Operative Day One to 12 MonthsPopulation: No data was collected for the Plain Balloon Angioplasty group
The change in lumen volume (LV) relative to total vessel volume (TVV) of the treated segment between the postoperative and 12 month time points as measured by MRI
Outcome measures
| Measure |
Dexamethasone
n=5 Participants
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=4 Participants
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Change in Lumen Volume (LV) Relative to Total Vessel Volume (TVV)
|
-12.3 mm*3
Standard Deviation 11.6
|
-3.88 mm*3
Standard Deviation 4.28
|
—
|
SECONDARY outcome
Timeframe: From Post-Operative Day One to 12 MonthsPercentage of subjects with clinically significant restenosis that undergo reintervention of greater than or equal to 75% of the treated segment by the 12 month timepoint.
Outcome measures
| Measure |
Dexamethasone
n=10 Participants
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=9 Participants
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
n=1 Participants
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Percentage of Subjects With Clinically Significant Restenosis That Undergo Reintervention of Greater Than or Equal to 75% of the Treated Segment
|
4 Participants
|
4 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Post-Operative Day One to 36 MonthsParticipant monitoring for clinical adverse events
Outcome measures
Outcome data not reported
Adverse Events
Dexamethasone
Serious events: 7 serious events
Other events: 1 other events
Deaths: 1 deaths
Drug-Coated Balloon
Serious events: 7 serious events
Other events: 1 other events
Deaths: 1 deaths
Plain Balloon Angioplasty
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone
n=10 participants at risk
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=9 participants at risk
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
n=1 participants at risk
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Cardiac disorders
Death
|
10.0%
1/10 • Number of events 1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
11.1%
1/9 • Number of events 1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
|
Vascular disorders
Reintervention requiring hospitalization
|
50.0%
5/10 • Number of events 10 • 36 months
Adverse Event data collection for 36 months after index procedure
|
66.7%
6/9 • Number of events 7 • 36 months
Adverse Event data collection for 36 months after index procedure
|
100.0%
1/1 • Number of events 2 • 36 months
Adverse Event data collection for 36 months after index procedure
|
|
Respiratory, thoracic and mediastinal disorders
COVID pneumonia requiring hospitalization
|
10.0%
1/10 • Number of events 1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/9 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
|
Cardiac disorders
Acute heart failure requiring admission
|
10.0%
1/10 • Number of events 1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/9 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
|
Vascular disorders
Arterial access site pseudoaneurysm requiring operation
|
0.00%
0/10 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/9 • 36 months
Adverse Event data collection for 36 months after index procedure
|
100.0%
1/1 • Number of events 1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
|
Cardiac disorders
Unstable angina requiring coronary revascularization
|
10.0%
1/10 • Number of events 1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/9 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
Other adverse events
| Measure |
Dexamethasone
n=10 participants at risk
Participants received dexamethasone infusion to the adventitia of the treated artery (1.6mg per cm of artery) following plain-old-balloon-angioplasty (POBA).
Dexamethasone infusion: Dexamethasone infusion to the artery adventitia (1.6mg per cm of artery) following plain balloon angioplasty
|
Drug-Coated Balloon
n=9 participants at risk
Participants received additional angioplasty with a paclitaxel drug-coated balloon (DCB) of the treated artery following plain-old-balloon-angioplasty (POBA).
Drug-coated balloon: Angioplasty with a paclitaxel drug-coated balloon following plain balloon angioplasty
|
Plain Balloon Angioplasty
n=1 participants at risk
Participants received plain-old-ballon-angioplasty (POBA) only.
Plain balloon angioplasty: Participants will receive plain balloon angioplasty only
|
|---|---|---|---|
|
Cardiac disorders
Pacemaker placement
|
10.0%
1/10 • Number of events 1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/9 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/10 • 36 months
Adverse Event data collection for 36 months after index procedure
|
11.1%
1/9 • 36 months
Adverse Event data collection for 36 months after index procedure
|
0.00%
0/1 • 36 months
Adverse Event data collection for 36 months after index procedure
|
Additional Information
Warren Gasper, MD
University of California, San Francisco
Phone: 415-353-4366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place