Claudication, Peripheral Arterial Disease
Conditions
Keywords
Peripheral arterial disease, claudication, drug-coated balloon, drug-eluting balloon
Brief summary
This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.
Interventions
DEVICECVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
DEVICEBare Percutaneous Transluminal Angioplasty Balloon Catheter
Sponsors
Spectranetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries * Rutherford clinical category 2, 3 or 4 * Male or non-pregnant female at least 18 years
Exclusion criteria
* Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries * Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy * Known intolerance of study medications, paclitaxel or contrast agent * Active participation in another investigational device or drug study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency at 12-months | 12 months | The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR). |
| Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month | 30-Days and 12-Months | The primary safety endpoint was 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 (CD-TLR) through 12 months post-procedure. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel-coated Balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | 222 |
| Paclitaxel-coated Balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | 254 |
| Bare Balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
Bare Percutaneous Transluminal Angioplasty Balloon Catheter | 72 |
| Bare Balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
Bare Percutaneous Transluminal Angioplasty Balloon Catheter | 79 |
| Total | 627 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 35 | 9 |
| Overall Study | Lost to Follow-up | 13 | 3 |
| Overall Study | Withdrawal by Subject | 28 | 14 |
Baseline characteristics
| Characteristic | Paclitaxel-coated Balloon | Bare Balloon | Total |
|---|---|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 9.2 | 69.0 years STANDARD_DEVIATION 8.6 | 67.3 years STANDARD_DEVIATION 9.1 |
| Baseline Ankle Brachial Index | 0.72 ratio STANDARD_DEVIATION 0.21 | 0.69 ratio STANDARD_DEVIATION 0.26 | 0.71 ratio STANDARD_DEVIATION 0.22 |
| Body Mass Index (BMI) | 27.2 kg/m^2 STANDARD_DEVIATION 4.7 | 27.8 kg/m^2 STANDARD_DEVIATION 4.7 | 27.3 kg/m^2 STANDARD_DEVIATION 4.7 |
| Calcification Moderate | 79 lesions | 24 lesions | 103 lesions |
| Calcification None/Mild | 140 lesions | 47 lesions | 187 lesions |
| Calcification Severe | 32 lesions | 8 lesions | 40 lesions |
| Diabetes | 83 Participants | 26 Participants | 109 Participants |
| Diameter stenosis | 78.7 % Diameter Stenosis STANDARD_DEVIATION 16 | 80.8 % Diameter Stenosis STANDARD_DEVIATION 15.7 | 79.2 % Diameter Stenosis STANDARD_DEVIATION 15.9 |
| Hyperlipidemia | 137 Participants | 49 Participants | 186 Participants |
| Hypertension | 173 Participants | 60 Participants | 233 Participants |
| Lesion length (mm) | 71.8 mm STANDARD_DEVIATION 51.9 | 70.8 mm STANDARD_DEVIATION 52.7 | 71.6 mm STANDARD_DEVIATION 52 |
| Lesion type De novo | 234 lesions | 71 lesions | 305 lesions |
| Lesion type Restonotic | 20 lesions | 8 lesions | 28 lesions |
| # of patent run-off vessels 0 | 18 Participants | 4 Participants | 22 Participants |
| # of patent run-off vessels 1 | 40 Participants | 9 Participants | 49 Participants |
| # of patent run-off vessels 2 | 68 Participants | 31 Participants | 99 Participants |
| # of patent run-off vessels 3 | 85 Participants | 24 Participants | 109 Participants |
| pre-dilatation performed | 254 lesions | 78 lesions | 332 lesions |
| Reference vessel Diameter | 5.02 mm STANDARD_DEVIATION 0.79 | 4.77 mm STANDARD_DEVIATION 0.69 | 4.96 mm STANDARD_DEVIATION 0.78 |
| Rutherford Clinical Category Rutherford Clinical Category 2 | 34 Participants | 15 Participants | 49 Participants |
| Rutherford Clinical Category Rutherford Clinical Category 3 | 183 Participants | 55 Participants | 238 Participants |
| Rutherford Clinical Category Rutherford Clinical Category 4 | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Female | 62 Participants | 23 Participants | 85 Participants |
| Sex: Female, Male Male | 160 Participants | 49 Participants | 209 Participants |
| Smoking status Never Smoked | 24 Participants | 12 Participants | 36 Participants |
| Smoking status Previous or current | 198 Participants | 60 Participants | 258 Participants |
| Total Occlusion | 48 lesions | 15 lesions | 63 lesions |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 35 / 219 | 9 / 68 |
| other Total, other adverse events | 180 / 219 | 51 / 68 |
| serious Total, serious adverse events | 118 / 219 | 38 / 68 |
Outcome results
Primary
Patency at 12-months
The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR).
Time frame: 12 months
Population: The analysis for the primary patency was based on the lesion success and not participant success. In the Paclitaxel-coated balloon arm, 222 subjects represents 254 lesions. Of those 254 lesions, only 224 lesions were evaluable. In the Bare balloon arm, 72 subjects represents 79 lesions. Of those 79 lesions, only 66 lesions were evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel-coated Balloon | Patency at 12-months | 83.9 percentage of lesions |
| Bare Balloon | Patency at 12-months | 60.6 percentage of lesions |
Primary
Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month
The primary safety endpoint was 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 (CD-TLR) through 12 months post-procedure.
Time frame: 30-Days and 12-Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paclitaxel-coated Balloon | Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month | 94.1 percentage of participants |
| Bare Balloon | Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month | 83.3 percentage of participants |