Trial Outcomes & Findings for Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon (NCT NCT01858428)

Last Updated: 2020-08-24

Results Overview

Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

Recruitment status

COMPLETED

Study phase

Target enrollment

300 participants

Primary outcome timeframe

12 months

Results posted on

2020-08-24

Participant Flow

Randomization. Patients who provided written informed consent but were excluded from the study due to not meeting all of the inclusion criteria or meeting one or more of the exclusion criteria were screen failures. Subjects who had unsuccessful pre-dilatation were not randomized and were to be treated per the institution's standard of care.

Participant milestones

Participant milestones
Measure	Bare PTA EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Overall Study STARTED	100	200
Overall Study COMPLETED	99	190
Overall Study NOT COMPLETED	1	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Not all participants disclosed race or ethnicity.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bare PTA n=100 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=200 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.	Total n=300 Participants Total of all reporting groups
Age, Customized Age	69.8 years STANDARD_DEVIATION 9.8 • n=100 Participants	68.3 years STANDARD_DEVIATION 10.3 • n=200 Participants	68.8 years STANDARD_DEVIATION 10.1 • n=300 Participants
Sex: Female, Male Female	36 Participants n=100 Participants	88 Participants n=200 Participants	124 Participants n=300 Participants
Sex: Female, Male Male	64 Participants n=100 Participants	112 Participants n=200 Participants	176 Participants n=300 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=96 Participants • Not all participants disclosed race or ethnicity.	2 Participants n=190 Participants • Not all participants disclosed race or ethnicity.	2 Participants n=286 Participants • Not all participants disclosed race or ethnicity.
Race/Ethnicity, Customized Asian	1 Participants n=96 Participants • Not all participants disclosed race or ethnicity.	2 Participants n=190 Participants • Not all participants disclosed race or ethnicity.	3 Participants n=286 Participants • Not all participants disclosed race or ethnicity.
Race/Ethnicity, Customized Black or African American	19 Participants n=96 Participants • Not all participants disclosed race or ethnicity.	35 Participants n=190 Participants • Not all participants disclosed race or ethnicity.	54 Participants n=286 Participants • Not all participants disclosed race or ethnicity.
Race/Ethnicity, Customized White	68 Participants n=96 Participants • Not all participants disclosed race or ethnicity.	142 Participants n=190 Participants • Not all participants disclosed race or ethnicity.	210 Participants n=286 Participants • Not all participants disclosed race or ethnicity.
Race/Ethnicity, Customized Other	8 Participants n=96 Participants • Not all participants disclosed race or ethnicity.	9 Participants n=190 Participants • Not all participants disclosed race or ethnicity.	17 Participants n=286 Participants • Not all participants disclosed race or ethnicity.
Region of Enrollment Austria	10 participants n=100 Participants	17 participants n=200 Participants	27 participants n=300 Participants
Region of Enrollment United States	90 participants n=100 Participants	183 participants n=200 Participants	273 participants n=300 Participants
Ankle-Brachial Index	0.76 ratio STANDARD_DEVIATION 0.20 • n=100 Participants	0.75 ratio STANDARD_DEVIATION 0.21 • n=200 Participants	0.75 ratio STANDARD_DEVIATION 0.21 • n=300 Participants
Rutherford Becker Clinical Category Rutherford 2	35 participants n=100 Participants	63 participants n=200 Participants	98 participants n=300 Participants
Rutherford Becker Clinical Category Rutherford 3	60 participants n=100 Participants	129 participants n=200 Participants	189 participants n=300 Participants
Rutherford Becker Clinical Category Rutherford 4	5 participants n=100 Participants	8 participants n=200 Participants	13 participants n=300 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have been eligible for failures carried forward or had a Clinically driven target lesion revasc (CD-TLR) prior to study exit.

Outcome measures

Outcome measures
Measure	Bare PTA n=92 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=177 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Patency at 12 Month Post-procedure	53 Participants	135 Participants

PRIMARY outcome

Timeframe: 30 Days and 12 months

Population: Some Safety Status Missing at 12 Months Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have had a primary safety event within 12 months prior to study exit.

Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.

Outcome measures

Outcome measures
Measure	Bare PTA n=95 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=189 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization	79 Participants	174 Participants

SECONDARY outcome

Timeframe: 1, 6, 12, 24, 36, 48 and 60 months

Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Outcome measures

Outcome measures
Measure	Bare PTA n=96 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=191 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure	17 Events	18 Events

SECONDARY outcome

Timeframe: in-hospital and 1, 6, 12 and 24 months

Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.

Outcome measures

Outcome measures
Measure	Bare PTA n=95 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=190 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Rate of Vascular Access and Bleeding Complications	3 participants	8 participants

SECONDARY outcome

Timeframe: 6, 12, 24, 36, 48 and 60 months

Outcome measures

Outcome measures
Measure	Bare PTA n=95 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=189 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Rate of Clinically-driven Target Lesion Revascularization	15 participants	16 participants

SECONDARY outcome

Timeframe: 6, 12, 24, 36, 48 and 60 months

Outcome measures

Outcome measures
Measure	Bare PTA n=95 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=189 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Rate of Target Lesion Revascularization	17 participants	18 participants

SECONDARY outcome

Timeframe: 1, 6, 12, 24, 36, 48 and 60 months

Outcome measures

Outcome measures
Measure	Bare PTA n=95 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=189 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Rate of Target Limb Major Amputation	0 participants	0 participants

SECONDARY outcome

Timeframe: 6, 12, 24, 36, 48 and 60 months

Outcome measures

Outcome measures
Measure	Bare PTA n=96 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=192 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Mortality Rate	2 participants	5 participants

SECONDARY outcome

Timeframe: 1, 6, 12, 24, 36, 48 and 60 months

Outcome measures

Outcome measures
Measure	Bare PTA n=95 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=189 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	0 participants	2 participants

SECONDARY outcome

Timeframe: 6, 24 and 36 months

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months

Outcome measures

Outcome measures
Measure	Bare PTA n=84 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=152 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Patency Rate and Freedom From Clinically-driven TLR	58 participants	133 participants

SECONDARY outcome

Timeframe: procedure, Day 0

Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.

Outcome measures

Outcome measures
Measure	Bare PTA n=100 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=199 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%	98 participants	196 participants

SECONDARY outcome

Timeframe: procedure, Day 0

Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.

Outcome measures

Outcome measures
Measure	Bare PTA n=100 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=199 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%	98 Lesion	196 Lesion

SECONDARY outcome

Timeframe: procedure, Day 0

Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.

Outcome measures

Outcome measures
Measure	Bare PTA n=100 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=199 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure	98 participants	196 participants

SECONDARY outcome

Timeframe: procedure, Day 0

Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.

Outcome measures

Outcome measures
Measure	Bare PTA n=100 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=199 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure	98 Participants	196 Participants

SECONDARY outcome

Timeframe: 6, 12, 24 and 36 months

Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.

Outcome measures

Outcome measures
Measure	Bare PTA n=91 Participants EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=167 Participants Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
Change in Ankle-brachial Index (ABI) From Pre-procedure	69 Participants	132 Participants

Adverse Events

Bare PTA

Serious events: 63 serious events

Other events: 85 other events

Deaths: 2 deaths

Drug-Coated PTA

Serious events: 120 serious events

Other events: 162 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Bare PTA n=100 participants at risk EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	Drug-Coated PTA n=200 participants at risk Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
General disorders Chest Pain	6.0% 6/100 • Number of events 6 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	7.0% 14/200 • Number of events 20 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
General disorders Oedema Peripheral	5.0% 5/100 • Number of events 5 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	3.5% 7/200 • Number of events 7 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Injury, poisoning and procedural complications Peripheral Artery Restenosis	11.0% 11/100 • Number of events 13 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	6.0% 12/200 • Number of events 12 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Musculoskeletal and connective tissue disorders Arthralagia	10.0% 10/100 • Number of events 10 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	7.0% 14/200 • Number of events 14 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Musculoskeletal and connective tissue disorders Back Pain	5.0% 5/100 • Number of events 5 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	6.0% 12/200 • Number of events 12 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Musculoskeletal and connective tissue disorders Muscle Spasms	4.0% 4/100 • Number of events 4 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	5.0% 10/200 • Number of events 11 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Musculoskeletal and connective tissue disorders Pain In Extremity	13.0% 13/100 • Number of events 13 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	12.0% 24/200 • Number of events 30 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.0% 3/100 • Number of events 4 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	5.0% 10/200 • Number of events 10 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Vascular disorders Femoral Artery Dissection	6.0% 6/100 • Number of events 6 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	8.5% 17/200 • Number of events 19 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Vascular disorders Intermittent Claudication	17.0% 17/100 • Number of events 19 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	16.5% 33/200 • Number of events 49 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.
Vascular disorders Peripheral Artery Stenosis	26.0% 26/100 • Number of events 34 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.	15.5% 31/200 • Number of events 39 • 12 months Events are stratified by MedDRA system organ class (SOC) and preferred term (PT). Subjects may experience multiple event types, thus the sum of the subjects by PT need not equal the total number of subjects in the summary for each SOC. In cases where the event verbatim term was updated by the Clinical Events Committee (CEC), the MedDRA coding was based on the event verbatim term provided by the CEC. Otherwise, the MedDRA coding was based on the site-reported event verbatim term.

Additional Information

Julie Wolfram Smith

Spectranetics

Phone: 763-955-1072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60