Peripheral Artery Disease
Conditions
Keywords
Angioplasty, Peripheral Artery Disease, PAD, Lesion, Claudication
Brief summary
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.
Interventions
DEVICETack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
Sponsors
Philips Clinical & Medical Affairs Global
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
* Subject must meet all of the following inclusion criteria to be eligible for enrollment: 1. Male or non-pregnant Female ≥ 18 years of age at the time of consent 2. Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception through the duration of the study (abstinence is acceptable) 3. Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure 4. Subject or has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the Informed Consent Form, an impartial witness may sign on behalf of the subject 5. Willing to comply with all required follow-up visits 6. Rutherford Classification 2, 3 or 4 7. Estimated life expectancy \>1 year 8. Eligible for standard surgical repair, if necessary 9. Subject is ambulatory (assistive devices such as a cane or walker is acceptable)
Exclusion criteria
* Subject must NOT meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months | 12 Months | Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) \>2.5) |
| Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days | 30 Days | Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days. |
Countries
Austria, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tack Endovascular System (6F) Use of the Tack Endovascular System (6F) in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s). | 213 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Missed 12-month Follow-up | 9 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Tack Endovascular System (6F) |
|---|---|
| ABI in contralateral limb | 0.90 ratio STANDARD_DEVIATION 0.18 |
| Age, Continuous | 68.2 years STANDARD_DEVIATION 9.1 |
| Ankle-brachial index (ABI) in treated leg | 0.76 ratio STANDARD_DEVIATION 0.21 |
| BMI | 29.3 Kg/m^2 STANDARD_DEVIATION 6.1 |
| BMI less than or equal to 30 | 83 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 29 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 | 0 Participants |
| Race (NIH/OMB) White | 181 Participants |
| Region of Enrollment Austria | 40 participants |
| Region of Enrollment United States | 173 participants |
| Rutherford Classification 2 | 68 participants |
| Rutherford Classification 3 | 136 participants |
| Rutherford Classification 4 | 9 participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 213 |
| other Total, other adverse events | 139 / 213 |
| serious Total, serious adverse events | 115 / 213 |
Outcome results
Primary
Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months
Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) \>2.5)
Time frame: 12 Months
Population: ITT population with available data for this assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tack Endovascular System (6F) | Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months | 120 Participants |
Primary
Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days
Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.
Time frame: 30 Days
Population: ITT population with available data for this assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tack Endovascular System (6F) | Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days | 212 Participants |