Trial Outcomes & Findings for CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery (NCT NCT05734157)
NCT ID: NCT05734157
Last Updated: 2025-09-19
Results Overview
Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).
COMPLETED
NA
75 participants
6 months post procedure
2025-09-19
Participant Flow
A total seventy-five (75) subjects were enrolled in the CVT-SFA study at eight (8) investigational sites in Europe between February 17, 2022, and September 01, 2022.
Participant milestones
| Measure |
Everolimus-coated Balloon
The Chansu Vascular Technologies (CVT) Everolimus-coated PTA Catheter is an angioplasty catheter designed to facilitate percutaneous treatment of subjects with documented symptomatic occlusion and/or \>70% stenosis of the SFA or popliteal (P1 segment) artery.
The CVT Everolimus-coated PTA Catheter is comprised of two main components:
1. A CE-marked, commercially-available PTA balloon catheter designed to treat peripheral vascular artery lesions. The PTA catheters are also previously cleared by FDA for peripheral (PTA) angioplasty indications.
2. A drug coating comprised of an approved, commercially-available active pharmaceutical agent (API) mixed with an approved commercially-available excipi Theent. active pharmaceutical agent is the drug everolimus, in crystalline form, and it is applied onto the balloon using a glycerol ester excipient. Everolimus, like sirolimus, is an mTOR inhibitor drug with cytostatic properties. Everolimus is currently used in CE mark and FDA approved coronary drug-eluting stents \[Promus (Boston Scientific), Xience (Abbott Vascular), Synergy (Boston Scientific)\].
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Everolimus-coated Balloon
The Chansu Vascular Technologies (CVT) Everolimus-coated PTA Catheter is an angioplasty catheter designed to facilitate percutaneous treatment of subjects with documented symptomatic occlusion and/or \>70% stenosis of the SFA or popliteal (P1 segment) artery.
The CVT Everolimus-coated PTA Catheter is comprised of two main components:
1. A CE-marked, commercially-available PTA balloon catheter designed to treat peripheral vascular artery lesions. The PTA catheters are also previously cleared by FDA for peripheral (PTA) angioplasty indications.
2. A drug coating comprised of an approved, commercially-available active pharmaceutical agent (API) mixed with an approved commercially-available excipi Theent. active pharmaceutical agent is the drug everolimus, in crystalline form, and it is applied onto the balloon using a glycerol ester excipient. Everolimus, like sirolimus, is an mTOR inhibitor drug with cytostatic properties. Everolimus is currently used in CE mark and FDA approved coronary drug-eluting stents \[Promus (Boston Scientific), Xience (Abbott Vascular), Synergy (Boston Scientific)\].
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Telephone call
|
3
|
Baseline Characteristics
CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
Baseline characteristics by cohort
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Hypertension
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate
|
72 Participants
|
PRIMARY outcome
Timeframe: 6 months post procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Freedom from restenosis as determined by duplex ultrasonography (DUS) (peak systolic velocity ratio (PSVR) ≤2.4 or ≤50% stenosis) and freedom from ischemia-driven target lesion revascularization (TLR).
Outcome measures
| Measure |
Everolimus-coated Balloon
n=68 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR)
|
63 Participants
|
SECONDARY outcome
Timeframe: In HospitalPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR). The time frame for "In hospital" refers to time from procedure to discharge. This timeframe is different for every enrolled subject. The subject is discharged at the treating physician's discretion based on their specific treatment needs.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Rate of Major Adverse Event (MAE)
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 Days Post-procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Rate of Major Adverse Event (MAE)
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 months Post-procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
Outcome measures
| Measure |
Everolimus-coated Balloon
n=72 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Rate of Major Adverse Event (MAE)
|
67 Participants
|
SECONDARY outcome
Timeframe: 12monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Rate of occurrence arterial thrombosis of the treated segment as determined by QVA
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Rate of Ipsilateral Embolic Events of the Study Limb
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
This end point was to asses the Rate of Clinically-driven Revascularization.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=74 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Rate of Clinically-driven Revascularization
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
This end point was to asses the Rate of Clinically-driven Revascularization.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=72 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Rate of Clinically-driven Revascularization
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=67 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Patency Rate
|
61 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Rate of vascular access site complication defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair or transfusion, prolonged hospital stay, or required a new hospital admission.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Rate of Vascular Access Site Complication
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Lesion success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \<50% (by QA), using any device after wire passage through the lesion. Pre- and post-dilatation of the lesion with a non-study device is considered part of assigned device treatment.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=86 Lesions
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Lesion Success
|
85 Lesions
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Technical success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \<50% (by QA), using the CVT Everolimus-coated PTA Catheter without a device malfunction after wire passage through the lesion. Pre- and postdilatation are considered part of assigned device treatment.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=86 lesions
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Technical Success
|
85 lesions
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Clinical success (per subject) defined as technical success without the occurrence of major adverse events (MAE) during the procedure.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Clinical Success
|
75 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Procedural Success
|
75 Participants
|
SECONDARY outcome
Timeframe: DischargePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=71 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Change in Ankle-Brachial Index (ABI)
|
61 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=71 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Change in Ankle-Brachial Index (ABI)
|
69 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=71 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Change in Ankle-Brachial Index (ABI)
|
61 Participants
|
SECONDARY outcome
Timeframe: Pre-Procedure to 6 months and 12 monthsPopulation: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on degree of difficulty, according to approximate number of feet, stairs, or miles per hour for distance, stair-climbing, and speed scores, respectively. Scores are then divided by maximum number of points and presented on a scale of 0% to 100%, where 0% represents lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less difficulty with walking, while a lower score signifies greater difficulty with walking.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty
Pre procedure
|
31.3 score on a scale
Standard Deviation 29.7
|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty
6 months
|
78.0 score on a scale
Standard Deviation 36.9
|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty
12 months
|
80.8 score on a scale
Standard Deviation 35.6
|
SECONDARY outcome
Timeframe: Pre-Procedure to 6 months and 12 monthsPopulation: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). Higher scores signify less difficulty in maintaining speed while walking.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed
Pre procedure
|
19.0 score on a scale
Standard Deviation 16.7
|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed
6 months
|
46.6 score on a scale
Standard Deviation 31.5
|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed
12 months
|
44.9 score on a scale
Standard Deviation 31.7
|
SECONDARY outcome
Timeframe: Pre-Procedure to 6 months and 12 monthsPopulation: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less perceived walking impairment.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment
Pre procedure
|
75.9 score on a scale
Standard Deviation 17.6
|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment
6 months
|
85.3 score on a scale
Standard Deviation 17.8
|
|
Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment
12 months
|
89.9 score on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Baseline to 6 months and 12 monthsPopulation: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
The Walking Test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=73 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Walking Test: Change in Walking Distance
Baseline
|
231.3 meters
Standard Deviation 93.6
|
|
Walking Test: Change in Walking Distance
6 months
|
382.8 meters
Standard Deviation 151.7
|
|
Walking Test: Change in Walking Distance
12 months
|
399.6 meters
Standard Deviation 138.6
|
SECONDARY outcome
Timeframe: Baseline to 6 months and 12 monthsPopulation: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
Treadmill walking test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD).
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Treadmill Test: Change in Walking Distance
Baseline
|
80.9 meters
Standard Deviation 52.8
|
|
Treadmill Test: Change in Walking Distance
6 months
|
104.0 meters
Standard Deviation 72.7
|
|
Treadmill Test: Change in Walking Distance
12 months
|
106.0 meters
Standard Deviation 74.6
|
SECONDARY outcome
Timeframe: Pre-procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings. Class 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \> 50 mm Hg but at least 20 mm Hg lower than resting value. Class 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \< 50 mm Hg. Class 4 critical limb ischemia resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \< 30 mm Hg. Class 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \< 40 mm Hg. The lower the RB Class the better the outcome.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=75 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Change in Rutherford Classification
Class 0
|
0 Participants
|
|
Change in Rutherford Classification
Class 1
|
0 Participants
|
|
Change in Rutherford Classification
Class 2
|
12 Participants
|
|
Change in Rutherford Classification
Class 3
|
53 Participants
|
|
Change in Rutherford Classification
Class 4
|
9 Participants
|
|
Change in Rutherford Classification
Class 5
|
1 Participants
|
|
Change in Rutherford Classification
Class 6
|
0 Participants
|
|
Change in Rutherford Classification
Not Done
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings. Class 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \> 50 mm Hg but at least 20 mm Hg lower than resting value. Class 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \< 50 mm Hg. Class 4 critical limb ischemia resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \< 30 mm Hg. Class 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \< 40 mm Hg. The lower the RB Class the better the outcome.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=74 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Change in Rutherford Classification
Class 0
|
51 Participants
|
|
Change in Rutherford Classification
Class 1
|
6 Participants
|
|
Change in Rutherford Classification
Class 2
|
7 Participants
|
|
Change in Rutherford Classification
Class 3
|
6 Participants
|
|
Change in Rutherford Classification
Class 4
|
0 Participants
|
|
Change in Rutherford Classification
Class 5
|
0 Participants
|
|
Change in Rutherford Classification
Class 6
|
0 Participants
|
|
Change in Rutherford Classification
Not Done
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings. Class 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \> 50 mm Hg but at least 20 mm Hg lower than resting value. Class 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \< 50 mm Hg. Class 4 critical limb ischemia resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \< 30 mm Hg. Class 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \< 40 mm Hg. The lower the RB Class the better the outcome.
Outcome measures
| Measure |
Everolimus-coated Balloon
n=72 Participants
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Change in Rutherford Classification
Class 0
|
51 Participants
|
|
Change in Rutherford Classification
Class 1
|
3 Participants
|
|
Change in Rutherford Classification
Class 2
|
5 Participants
|
|
Change in Rutherford Classification
Class 3
|
7 Participants
|
|
Change in Rutherford Classification
Class 4
|
0 Participants
|
|
Change in Rutherford Classification
Class 5
|
0 Participants
|
|
Change in Rutherford Classification
Class 6
|
0 Participants
|
|
Change in Rutherford Classification
Not Done
|
6 Participants
|
Adverse Events
Everolimus-coated Balloon
Serious adverse events
| Measure |
Everolimus-coated Balloon
n=75 participants at risk
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/75 • Baseline to 12 months
|
|
Cardiac disorders
Coronary artery disease
|
9.3%
7/75 • Baseline to 12 months
|
|
Cardiac disorders
Death during heart surgery
|
1.3%
1/75 • Baseline to 12 months
|
|
Cardiac disorders
Heart attack
|
1.3%
1/75 • Baseline to 12 months
|
|
Cardiac disorders
Partial Infarct
|
1.3%
1/75 • Baseline to 12 months
|
|
Cardiac disorders
Right ventricular implant repair
|
1.3%
1/75 • Baseline to 12 months
|
|
Gastrointestinal disorders
Colon tumor
|
1.3%
1/75 • Baseline to 12 months
|
|
Gastrointestinal disorders
Epigastric pain
|
1.3%
1/75 • Baseline to 12 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.3%
1/75 • Baseline to 12 months
|
|
Gastrointestinal disorders
Inflammatory bladder
|
1.3%
1/75 • Baseline to 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Cancer
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Terminal cancer
|
2.7%
2/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Aneurysm spurium
|
2.7%
2/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Distal embolism
|
1.3%
1/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Revascularization
|
6.7%
5/75 • Baseline to 12 months
|
|
Musculoskeletal and connective tissue disorders
Spinal contusions
|
1.3%
1/75 • Baseline to 12 months
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.3%
1/75 • Baseline to 12 months
|
|
Nervous system disorders
Parkinson's Disease
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Stenosis, non-study limb
|
20.0%
15/75 • Baseline to 12 months
|
|
General disorders
Stenosis, non-study vessel
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Stenosis, non-target lesion
|
2.7%
2/75 • Baseline to 12 months
|
|
General disorders
Stenosis, target vessel
|
1.3%
1/75 • Baseline to 12 months
|
|
Renal and urinary disorders
Cystitis
|
1.3%
1/75 • Baseline to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.3%
1/75 • Baseline to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disease
|
1.3%
1/75 • Baseline to 12 months
|
|
Skin and subcutaneous tissue disorders
Nasal resection (squamous cell cancer)
|
1.3%
1/75 • Baseline to 12 months
|
|
Surgical and medical procedures
Glaucoma surgery
|
1.3%
1/75 • Baseline to 12 months
|
Other adverse events
| Measure |
Everolimus-coated Balloon
n=75 participants at risk
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
|
|---|---|
|
Blood and lymphatic system disorders
Hypertriglyceridemia
|
1.3%
1/75 • Baseline to 12 months
|
|
Cardiac disorders
Arrhythmia
|
1.3%
1/75 • Baseline to 12 months
|
|
Cardiac disorders
CRP increase at discharge
|
1.3%
1/75 • Baseline to 12 months
|
|
Cardiac disorders
Chest pain
|
4.0%
3/75 • Baseline to 12 months
|
|
Cardiac disorders
Irregular heartrate
|
1.3%
1/75 • Baseline to 12 months
|
|
Cardiac disorders
Thoracic pain
|
1.3%
1/75 • Baseline to 12 months
|
|
Gastrointestinal disorders
Burning pain in esophagus
|
1.3%
1/75 • Baseline to 12 months
|
|
Gastrointestinal disorders
Esophageal reflux
|
1.3%
1/75 • Baseline to 12 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Allergy to medication
|
2.7%
2/75 • Baseline to 12 months
|
|
General disorders
Angiography performed
|
6.7%
5/75 • Baseline to 12 months
|
|
General disorders
Bruises easily
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Bruising/hemotoma over body
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Calf claudication
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Calf pain
|
4.0%
3/75 • Baseline to 12 months
|
|
General disorders
Deep vein thrombosis, non-study limb
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Diabetes mellitus II
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Distal arteriopathy
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Dizzyness
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Glaucoma
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Groin bleeding
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Groin/scrotum hematoma (non-study limb)
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Haematoma, right arm
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Haematoma, wrist
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Hip pain
|
2.7%
2/75 • Baseline to 12 months
|
|
General disorders
Knee injury
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Knee pain
|
5.3%
4/75 • Baseline to 12 months
|
|
General disorders
Leg claudication, non-study limb
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Leg oedema, both legs
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Leg pain
|
4.0%
3/75 • Baseline to 12 months
|
|
General disorders
Lower body/limbs hot
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Lower leg swelling
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Necrosectomy, heel
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Oedema, non-study limb
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Pain, non-study limb
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Polyneuropathy, non-study limb
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Stenosis, non-TL
|
6.7%
5/75 • Baseline to 12 months
|
|
General disorders
Stenosis, non-study limb
|
2.7%
2/75 • Baseline to 12 months
|
|
General disorders
Swollen knee
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
TL occlusion, no action taken
|
6.7%
5/75 • Baseline to 12 months
|
|
General disorders
Teeth extraction
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Tension headache
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Tingling/numbing foot
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Toe pain
|
1.3%
1/75 • Baseline to 12 months
|
|
General disorders
Vertigo
|
1.3%
1/75 • Baseline to 12 months
|
|
Infections and infestations
Covid
|
1.3%
1/75 • Baseline to 12 months
|
|
Infections and infestations
Influenza
|
1.3%
1/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
AV fistula post-dilatation
|
1.3%
1/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Bleeding at groin puncture site
|
1.3%
1/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Distal embolism
|
1.3%
1/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Groin pain
|
2.7%
2/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Groin pain at puncture site
|
2.7%
2/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Hematoma at puncture site
|
2.7%
2/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Pain in lower leg
|
1.3%
1/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Perforation from guidewire
|
1.3%
1/75 • Baseline to 12 months
|
|
Injury, poisoning and procedural complications
Superficial thrombosis
|
1.3%
1/75 • Baseline to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/75 • Baseline to 12 months
|
|
Musculoskeletal and connective tissue disorders
Disc prolapse
|
1.3%
1/75 • Baseline to 12 months
|
|
Musculoskeletal and connective tissue disorders
Sciatica pain
|
1.3%
1/75 • Baseline to 12 months
|
|
Musculoskeletal and connective tissue disorders
Spinal canal stenosis
|
1.3%
1/75 • Baseline to 12 months
|
|
Renal and urinary disorders
Chronic kidney insufficiency
|
1.3%
1/75 • Baseline to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin tumor
|
1.3%
1/75 • Baseline to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60