Femoral Artery Occlusion, Femoral Artery Stenosis, Popliteal Artery Occlusion, Popliteal Artery Stenosis
Conditions
Keywords
TP1109, CVT-SFA, Femoral Artery Stenosis
Brief summary
The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.
Detailed description
The CVT-SFA Trial is a prospective, multi-center, open, single arm study enrolling subjects with de-novo or post-PTA occluded/stenotic or re-occluded/ restenotic lesions (excluding in-stent lesions) ≤150mm in length in femoropopliteal arteries with reference vessel diameters of 4-6mm, receiving up to two (2) CVT Everolimus-coated PTA Catheters to establish blood flow and to maintain vessel patency.
Interventions
DEVICEPeripheral PTA with a drug coated balloon
Peripheral artery angioplasty
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be at least 18 years of age. 2. Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site. 3. Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations. 4. Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery. 5. De novo or restenotic lesion(s) \>70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). Lesion must be at least 2 cm from any stented area. 6. Subject is willing to comply with the required follow up visits, testing schedule and medication regimen. 7. Successful wire crossing of lesion. 8. Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation). 9. Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated PTA Catheters. 10. At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior MR angiography or CT angiography. 11. Life expectancy \>1 year 12. Rutherford classification of 2, 3 or 4.
Exclusion criteria
1. Pregnant or lactating females. 2. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries. 3. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy. 4. Known intolerance to study medications, everolimus or contrast agents. 5. Doubts in the willingness or capability of the subject to allow follow-up examinations. 6. Subject is actively participating in another investigational device or drug study. 7. History of hemorrhagic stroke within 3 months of procedure. 8. Previous or planned surgical or interventional procedure within 30 days of index procedure. 9. Prior vascular surgery of the target lesion. 10. Lesion length is \<3 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured. 11. Known inadequate distal outflow. 12. Significant inflow disease. 13. Acute or sub-acute thrombus in target vessel. 14. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy, lithotripsy). 15. Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure. 16. Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure. 17. Rutherford classification of 0, 1, 5 or 6 18. Presence of prohibitive calcification that precludes adequate PTA treatment. 19. Subjects held in custody in an institution by official or court order.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate | 6 months post procedure | Freedom from MAEs defined as a composite rate of cardiovascular death, index limb amputation, and ischemia-driven TLR. |
| The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR) | 6 months post procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Event (MAE) | In Hospital | 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. |
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 12months | Rate of occurrence arterial thrombosis of the treated segment as determined by QVA |
| Rate of Ipsilateral Embolic Events of the Study Limb | 12 months | This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb. |
| Rate of Clinically-driven Target Lesion Revascularization | 6 months | This end point was to asses the Rate of Clinically-driven Revascularization. |
| Patency Rate | 12 months | The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures. |
| Rate of Vascular Access Site Complication | 12 months | 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. |
| Lesion Success | 12 months | 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. |
| Technical Success | 12 months | 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. |
| Clinical Success | 12 months | Clinical success (per subject) defined as technical success without the occurrence of major adverse events (MAE) during the procedure. |
| Procedural Success | 12 months | Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure. |
| Change in Ankle-Brachial Index (ABI) | Discharge | 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. |
| Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty | Pre-Procedure to 6 months and 12 months | 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. |
| Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed | Pre-Procedure to 6 months and 12 months | 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. |
| Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment | Pre-Procedure to 6 months and 12 months | 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. |
| Walking Test: Change in Walking Distance | Baseline to 6 months and 12 months | 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. |
| Treadmill Test: Change in Walking Distance | Baseline to 6 months and 12 months | Treadmill walking test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD). |
| Change in Rutherford Classification | Pre-procedure | 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. |
Countries
France, Germany
Participant flow
Recruitment details
A total seventy-six (76) subjects were enrolled in the CVT-SFA study at eight (8) investigational sites in France and Germany between February 17, 2022, and September 01, 2022.
Pre-assignment details
One subject was treated twice and assigned separate identification (ID) numbers. Follow-up data for each subject ID was entered separately; therefore, although 75 unique subjects were enrolled in this study, the subject treated twice is counted as 2 separate subjects for the purposes of analysis (i.e., 76 subjects treated).
Participants by arm
| Arm | Count |
|---|---|
| Everolimus-coated Balloon Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon. | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Everolimus-coated Balloon |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Hypertension | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 63 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 76 |
| other Total, other adverse events | 29 / 76 |
| serious Total, serious adverse events | 46 / 76 |
Outcome results
Primary
Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate
Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).
Time frame: 6 months post procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate | 72 Participants |
Primary
The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR)
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).
Time frame: 6 months post procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR) | 63 Participants |
Secondary
Change in Ankle-Brachial Index (ABI)
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.
Time frame: Discharge
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Change in Ankle-Brachial Index (ABI) | 61 Participants |
Secondary
Change in Ankle-Brachial Index (ABI)
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.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Change in Ankle-Brachial Index (ABI) | 61 Participants |
Secondary
Change in Ankle-Brachial Index (ABI)
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.
Time frame: 6 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Change in Ankle-Brachial Index (ABI) | 69 Participants |
Secondary
Change in Rutherford Classification
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.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 0 | 51 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 3 | 7 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 1 | 3 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 2 | 5 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 4 | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 5 | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 6 | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Not Done | 6 Participants |
Secondary
Change in Rutherford Classification
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.
Time frame: Pre-procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 5 | 1 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Not Done | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 0 | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 1 | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 2 | 12 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 3 | 53 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 4 | 9 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 6 | 0 Participants |
Secondary
Change in Rutherford Classification
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.
Time frame: 6 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 3 | 6 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 4 | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 6 | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 0 | 51 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 1 | 6 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 2 | 7 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Class 5 | 0 Participants |
| Everolimus-coated Balloon | Change in Rutherford Classification | Not Done | 4 Participants |
Secondary
Clinical Success
Clinical success (per subject) defined as technical success without the occurrence of major adverse events (MAE) during the procedure.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Clinical Success | 75 Participants |
Secondary
Lesion Success
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.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus-coated Balloon | Lesion Success | 85 Lesions |
Secondary
Patency Rate
The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Patency Rate | 61 Participants |
Secondary
Procedural Success
Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Procedural Success | 75 Participants |
Secondary
Rate of Clinically-driven Revascularization
This end point was to asses the Rate of Clinically-driven Revascularization.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Rate of Clinically-driven Revascularization | 4 Participants |
Secondary
Rate of Clinically-driven Revascularization
This end point was to asses the Rate of Clinically-driven Revascularization.
Time frame: 6 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Rate of Clinically-driven Revascularization | 2 Participants |
Secondary
Rate of Ipsilateral Embolic Events of the Study Limb
This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Rate of Ipsilateral Embolic Events of the Study Limb | 2 Participants |
Secondary
Rate of Major Adverse Event (MAE)
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.
Time frame: In Hospital
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Rate of Major Adverse Event (MAE) | 0 Participants |
Secondary
Rate of Major Adverse Event (MAE)
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
Time frame: 12 months Post-procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Rate of Major Adverse Event (MAE) | 67 Participants |
Secondary
Rate of Major Adverse Event (MAE)
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
Time frame: 30 Days Post-procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Rate of Major Adverse Event (MAE) | 1 Participants |
Secondary
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence arterial thrombosis of the treated segment as determined by QVA
Time frame: 12months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 0 Participants |
Secondary
Rate of Vascular Access Site Complication
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.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus-coated Balloon | Rate of Vascular Access Site Complication | 2 Participants |
Secondary
Technical Success
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.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus-coated Balloon | Technical Success | 85 lesions |
Secondary
Treadmill Test: Change in Walking Distance
Treadmill walking test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD).
Time frame: Baseline to 6 months and 12 months
Population: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Everolimus-coated Balloon | Treadmill Test: Change in Walking Distance | Baseline | 80.9 meters | Standard Deviation 52.8 |
| Everolimus-coated Balloon | Treadmill Test: Change in Walking Distance | 6 months | 104.0 meters | Standard Deviation 72.7 |
| Everolimus-coated Balloon | Treadmill Test: Change in Walking Distance | 12 months | 106.0 meters | Standard Deviation 74.6 |
Secondary
Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty
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.
Time frame: Pre-Procedure to 6 months and 12 months
Population: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty | Pre procedure | 31.3 score on a scale | Standard Deviation 29.7 |
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty | 6 months | 78.0 score on a scale | Standard Deviation 36.9 |
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty | 12 months | 80.8 score on a scale | Standard Deviation 35.6 |
Secondary
Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment
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.
Time frame: Pre-Procedure to 6 months and 12 months
Population: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment | Pre procedure | 75.9 score on a scale | Standard Deviation 17.6 |
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment | 6 months | 85.3 score on a scale | Standard Deviation 17.8 |
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment | 12 months | 89.9 score on a scale | Standard Deviation 12.9 |
Secondary
Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed
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.
Time frame: Pre-Procedure to 6 months and 12 months
Population: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed | 12 months | 44.9 score on a scale | Standard Deviation 31.7 |
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed | Pre procedure | 19.0 score on a scale | Standard Deviation 16.7 |
| Everolimus-coated Balloon | Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed | 6 months | 46.6 score on a scale | Standard Deviation 31.5 |
Secondary
Walking Test: Change in Walking Distance
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.
Time frame: Baseline to 6 months and 12 months
Population: Number of participants who completed the Patient Reported Outcome (PRO) tool at each study time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Everolimus-coated Balloon | Walking Test: Change in Walking Distance | 6 months | 382.8 meters | Standard Deviation 151.7 |
| Everolimus-coated Balloon | Walking Test: Change in Walking Distance | Baseline | 231.3 meters | Standard Deviation 93.6 |
| Everolimus-coated Balloon | Walking Test: Change in Walking Distance | 12 months | 399.6 meters | Standard Deviation 138.6 |