Peripheral Arterial Disease
Conditions
Brief summary
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries. Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.
Detailed description
Cohort 1: The purpose of this single arm study is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. Cohort 2: A second cohort is being added to evaluate this patient population for treatment of in-stent restenotic lesions. Cohort 1: Prospective, multi-center, single-arm study. Cohort 2: Prospective, multi-center, single-arm study compared to a historical control. Cohort 1: Follow-up assessments will occur at discharge, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months following the study procedure. Cohort 2: Follow-up assessments will occur at discharge, 1 month, 6 months, 12 months, 24 months and 36 months following the study procedure.
Interventions
DEVICEStellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Sponsors
Spectranetics Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Cohort 1: General Inclusion Criteria: 1. Has symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery. 2. Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2 subjects should be entered into the study if conservative treatment has been unsuccessful. 3. Is ≥18 years old. 4. Has life expectancy \>1 year. 5. Is able and willing to provide written informed consent prior to study specific procedures. 6. Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen. Cohort 1: Angiographic Inclusion Criteria: 1. Has evidence at the target lesion(s) of clinically and hemodynamically significant de novo stenosis or restenosis, or occlusion, in the SFA (1 cm distal to the ostium of the profunda) and/or popliteal artery (proximal to the popliteal trifurcation), confirmed by angiography. 2. Has target limb with at least one patent (\<50% stenosis) tibio-peroneal run-off vessel to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or computed tomography angiography (CTA). Note: Treatment of outflow disease is NOT permitted. 3. Has 1 or 2 target lesion(s) with a cumulative lesion(s) length of no more than 20 cm. Note: A maximum of two (2) lesions can be treated if the cumulative total lesion length (i.e. the combined length of both lesions) is less than or equal to 20cm. 4. Has target lesion(s) located \>2 cm from any stent if the target vessel was previously stented. 5. Has a reference vessel diameter of 4 - 6 mm by visual estimate. 6. Has a successful exchangeable guidewire crossing of the lesion(s). Cohort 1: General
Exclusion criteria
1. A female who is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing; or a male intending to father children during the study. 2. Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy 3. Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated. 4. Is currently participating in another investigational device or drug study that would interfere with study endpoints. 5. Has history of hemorrhagic stroke within 3 months. 6. Has surgical or endovascular procedure of the target limb within 14 days prior to the index procedure. 7. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure. 8. Has had a previous peripheral bypass affecting the target limb. 9. Has unstable angina pectoris, myocardial infarction, liver failure, renal failure or chronic kidney disease (dialysis dependent, or serum creatinine ≥2.5 mg/dL) within 30 days of the index procedure. Cohort 1: Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Freedom From Device and Procedure-related Death and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization | Through 12 months post-procedure. | 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 (TLR) through 12 months post-procedure. |
| Percentage of Lesions Free From Restenosis | 12 months post-procedure. | Primary patency at 12 months post-procedure. Primary patency is defined as the absence of target lesion restenosis per duplex ultrasound (peak systolic velocity ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoint | 12 months post-procedure | The secondary efficacy outcome was freedom from target lesions revascularization (TLR) at 12 months post-procedure and compared to a performance goal. |
Countries
Australia, Austria, Belgium, France, Germany, Italy, New Zealand, Poland, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Global Cohort 1 The purpose of this single arm study is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries.
All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).
Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute. | 370 |
| ISR Cohort 2 Same patient population in Cohort 1, but cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions.
All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).
Stellarex 0.035 Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute. | 129 |
| Total | 499 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 37 | 3 |
| Overall Study | Lost to Follow-up | 10 | 2 |
| Overall Study | Missed last follow-up visit | 2 | 0 |
| Overall Study | Physician Decision | 9 | 0 |
| Overall Study | Withdrawal by Subject | 50 | 3 |
Baseline characteristics
| Characteristic | Total | ISR Cohort 2 | Global Cohort 1 |
|---|---|---|---|
| Age, Continuous | NA years | 69 years STANDARD_DEVIATION 9.4 | 68.2 years STANDARD_DEVIATION 9.3 |
| Baseline Ankle-Brachial Index | NA ratio | 0.66 ratio STANDARD_DEVIATION 0.18 | 0.70 ratio STANDARD_DEVIATION 0.2 |
| Baseline Rutherford-Becker Clinical Category RCC 1 | 1 Participants | 0 Participants | 1 Participants |
| Baseline Rutherford-Becker Clinical Category RCC 2 | 157 Participants | 33 Participants | 124 Participants |
| Baseline Rutherford-Becker Clinical Category RCC 3 | 299 Participants | 86 Participants | 213 Participants |
| Baseline Rutherford-Becker Clinical Category RCC 4 | 32 Participants | 9 Participants | 23 Participants |
| Baseline Rutherford-Becker Clinical Category RCC 5 | 10 Participants | 1 Participants | 9 Participants |
| Cerebrovascular Disease | 88 Participants | 25 Participants | 63 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) | 65 Participants | 16 Participants | 49 Participants |
| Coronary Heart Disease Angina Pectoris | 59 Participants | 10 Participants | 49 Participants |
| Coronary Heart Disease Congestive Heart Failure | 25 Participants | 11 Participants | 14 Participants |
| Coronary Heart Disease Myocardial Infarction | 85 Participants | 21 Participants | 64 Participants |
| Deep Vein Trhombosis | 10 Participants | 2 Participants | 8 Participants |
| Diabetes Type I | 5 Participants | 0 Participants | 5 Participants |
| Diabetes Type II | 168 Participants | 49 Participants | 119 Participants |
| Hyperlipidemia | 377 Participants | 101 Participants | 276 Participants |
| Hypertension | 396 Participants | 102 Participants | 294 Participants |
| Liver Disease | 18 Participants | 6 Participants | 12 Participants |
| Peripheral Vascular Disease | 422 Participants | 127 Participants | 295 Participants |
| Previous Percutaneous or Surgical Coronary Revascularization | 158 Participants | 35 Participants | 123 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 29 Participants | 0 Participants | 29 Participants |
| Race/Ethnicity, Customized Unknown | 6 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 455 Participants | 128 Participants | 327 Participants |
| Renal Insufficency | 46 Participants | 20 Participants | 26 Participants |
| Sex: Female, Male Female | 145 Participants | 46 Participants | 99 Participants |
| Sex: Female, Male Male | 354 Participants | 83 Participants | 271 Participants |
| Smoker Never Smoked | 89 Participants | 23 Participants | 66 Participants |
| Smoker Previous or Current Smoker | 410 Participants | 106 Participants | 304 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 37 / 370 | 3 / 122 |
| other Total, other adverse events | 343 / 370 | 93 / 122 |
| serious Total, serious adverse events | 291 / 370 | 65 / 122 |
Outcome results
Primary
Percentage of Lesions Free From Restenosis
Primary patency at 12 months post-procedure. Primary patency is defined as the absence of target lesion restenosis per duplex ultrasound (peak systolic velocity ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Time frame: 12 months post-procedure.
Population: The Modified Intention-to-Treat (mITT) will be comprised of all subjects in the ITT population who do not receive a bailout stent and did not receive provisional treatment for \>50% residual stenosis post all assigned treatment or bailout stenting. The primary analysis for both safety and efficacy will be based on the mITT population. In cohort 2, seven patients had bail-out stenting.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Global Cohort 1 | Percentage of Lesions Free From Restenosis | 77.8 percentage of lesions |
| Global ISR Cohort 2 | Percentage of Lesions Free From Restenosis | 58.8 percentage of lesions |
Primary
Percentage of Participants With Freedom From Device and Procedure-related Death and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
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 (TLR) through 12 months post-procedure.
Time frame: Through 12 months post-procedure.
Population: The Modified Intention-to-Treat (mITT) will be comprised of all subjects in the ITT population who do not receive a bailout stent and did not receive provisional treatment for \>50% residual stenosis post all assigned treatment or bailout stenting. The primary analysis for both safety and efficacy will be based on the mITT population. In cohort 2, seven patients had bail-out stenting.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Global Cohort 1 | Percentage of Participants With Freedom From Device and Procedure-related Death and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization | 94.8 percentage of participants |
| Global ISR Cohort 2 | Percentage of Participants With Freedom From Device and Procedure-related Death and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization | 84.1 percentage of participants |
Secondary
Secondary Efficacy Endpoint
The secondary efficacy outcome was freedom from target lesions revascularization (TLR) at 12 months post-procedure and compared to a performance goal.
Time frame: 12 months post-procedure
Population: The Modified Intention to-Treat (mITT) will be comprised of all subjects in the ITT population who do not receive a bailout stent and did not receive provisional treatment for \>50% residual stenosis post all assigned treatment or bailout stenting The primary analysis for safety and efficacy will be based on the mITT population In cohort 2, seven patients had bail-out stenting Data were only collected from Cohort 2 All data for prespecified Primary \& Secondary Outcome Measures should be reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Global Cohort 1 | Secondary Efficacy Endpoint | 83.5 percentage of participants |