PAD
Conditions
Brief summary
This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic PAD.
Detailed description
The primary objective of the clinical investigation is to evaluate the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries (SFA/PA) of patients with symptomatic PAD. The performance of the GORE® DCB Catheter is superior to a performance goal derived from literature reports of uncoated PTA balloons, measured six months after intervention.
Interventions
DEVICEDrug Coated Balloon
Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PAD patients with Rutherford Class 2 - 4 * De novo or restenotic lesions, including total occlusions of the SFA/PA * 1 lesion which may include one or more regions of luminal narrowing ≥70% with a total combined lesion length between 30 - 150mm and a reference vessel diameter of 4 - 6mm * 1 patent tibial or peroneal artery
Exclusion criteria
* Surgical or endovascular access in the Target limb/vessel within the previous 30 days * Prior treatment of the Target lesion with PTA within 90 days or any prior treatment with drug-coated balloon * Prior treatment of the Target vessel with stenting or bypass * Iliac artery inflow lesions that cannot be successfully treated during the Index procedure * Acute or subacute thrombus or arterial aneurysm in Target limb * Severe calcification that renders the Target lesion non-dilatable * Acute or chronic renal dysfunction (serum creatinine ≥2.5 mg/dL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss (LLL) | Six months | Six month late lumen loss (LLL) is defined as the difference in minimum lumen diameter of the Target lesion between the time points immediately post-intervention and the 6-month follow-up angiography or at the time of a Clinically Driven Target Lesion Revascularization (CD TLR), whichever is earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Freedom From Major Adverse Events | 30 days | A composite 30-day safety endpoint of freedom from Major Adverse Events (MAE), defined as i) death, ii) Clinically-Driven Target Vessel Revascularization (CD TVR), or iii) amputation above the metatarsals, resulting from a vascular event, in the treated leg (Target limb amputation). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug Coated Balloon Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter. | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Surgical bypass | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Drug Coated Balloon | — |
|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 8.6 | — |
| Mean Lesion Diameter Post Procedure(mm) | 4.01 milimeters STANDARD_DEVIATION 0.69 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 52 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 36 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 52 |
| other Total, other adverse events | 13 / 52 |
| serious Total, serious adverse events | 27 / 52 |
Outcome results
Primary
Late Lumen Loss (LLL)
Six month late lumen loss (LLL) is defined as the difference in minimum lumen diameter of the Target lesion between the time points immediately post-intervention and the 6-month follow-up angiography or at the time of a Clinically Driven Target Lesion Revascularization (CD TLR), whichever is earlier.
Time frame: Six months
Population: Of the 44 subjects completed the study, the late lumen loss was only available for 37 subjects, rest were treated as missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug Coated Balloon | Late Lumen Loss (LLL) | -0.17 mm | Standard Deviation 0.98 |
p-value: 095% CI: [-0.5, 0.152]t-test, 2 sided
Secondary
Number of Subjects With Freedom From Major Adverse Events
A composite 30-day safety endpoint of freedom from Major Adverse Events (MAE), defined as i) death, ii) Clinically-Driven Target Vessel Revascularization (CD TVR), or iii) amputation above the metatarsals, resulting from a vascular event, in the treated leg (Target limb amputation).
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Coated Balloon | Number of Subjects With Freedom From Major Adverse Events | 52 Participants |