Peripheral Arterial Disease
Conditions
Keywords
Angioplasty, Below the Knee, PAD, Critical Limb Ischemia, 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 the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.
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
* Males or non-pregnant females ≥ 18 years of age at the time of consent * Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception (abstinence is acceptable) through the duration of the study * Subject 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 (ICF), an impartial witness may sign on behalf of the subject * Willing to comply with all required follow-up visits * Rutherford Classification 4 or 5. * WIfI Wound grade of 0, 1 or modified 2. * WIfI Foot Infection grade of 0 or 1. * Estimated life expectancy ≥1 year
Exclusion criteria
* Is pregnant or refuses to use contraception through the duration of the study * Previous bypass graft in the target limb * Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure * Prior or planned above-ankle amputation or complete transmetatarsal amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridements) * WIfI Foot Infection grade 2 or 3 * Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12,000/or febrile state * Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb less than 30 days prior to or planned for less than 30 days after the index procedure * Existing stent implant in the target vessel * Any other endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) less than 14 days prior to the index procedure or planned procedure less than 30 days after the index procedure * Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter * WIfI Wound grade of 2 or 3. * Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated * Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the Index Procedure * History of stroke or transient ischemic attack (TIA) less than 90 days prior to the Index Procedure * Currently on dialysis * Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol) * Participating in another ongoing investigational clinical trial in which the subject has not completed the primary endpoint(s) * Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments * Known hypersensitivity or allergy to contrast agents that cannot be medically managed * Subject already enrolled into this study * Restenotic target lesion previously treated by means other than plain balloon angioplasty and/or less than 1 year prior to index procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days | 6 months | Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days. |
| Safety - Number of Participants With MALE Plus POD at 30 Days | 30 days | Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months | 6 months | Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency. |
| Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months | 6 months | Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months. |
Countries
Austria, Czechia, Germany, Hungary, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tack Endovascular System (4F) Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s). | 233 |
| Total | 233 |
Baseline characteristics
| Characteristic | Tack Endovascular System (4F) |
|---|---|
| ABI in treated limb | 0.74 ratio STANDARD_DEVIATION 0.27 |
| Age, Continuous | 74.4 years STANDARD_DEVIATION 10 |
| BMI | 28.8 Kg/m^2 STANDARD_DEVIATION 5.6 |
| BMI >= 30 | 86 Participants |
| Foot Infection Grade 0 | 194 Participants |
| Foot Infection Grade 1 | 39 Participants |
| Foot Infection Grade 2 | 0 Participants |
| Foot Infection Grade 3 | 0 Participants |
| Ischemia Grade 0 | 115 Participants |
| Ischemia Grade 1 | 55 Participants |
| Ischemia Grade 2 | 28 Participants |
| Ischemia Grade 3 | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 39 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 | 3 Participants |
| Race (NIH/OMB) White | 187 Participants |
| Rutherford Classification 0 | 0 Participants |
| Rutherford Classification 1 | 0 Participants |
| Rutherford Classification 2 | 0 Participants |
| Rutherford Classification 3 | 38 Participants |
| Rutherford Classification 4 | 78 Participants |
| Rutherford Classification 5 | 117 Participants |
| Rutherford Classification 6 | 0 Participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 157 Participants |
| TBI in treated limb | 0.43 ratio STANDARD_DEVIATION 0.23 |
| Wound Grade 0 | 122 Participants |
| Wound Grade 1 | 91 Participants |
| Wound Grade 2 | 0 Participants |
| Wound Grade 3 | 0 Participants |
| Wound Grade modified 2 | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 63 / 233 |
| other Total, other adverse events | 137 / 233 |
| serious Total, serious adverse events | 179 / 233 |
Outcome results
Primary
Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days
Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
Time frame: 6 months
Population: The number of evaluable subjects for the 6 Month Primacy Efficacy Endpoint was 209.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tack Endovascular System (4F) | Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days | 200 Participants |
Primary
Safety - Number of Participants With MALE Plus POD at 30 Days
Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
Time frame: 30 days
Population: Four subjects were not evaluable for the 30 Day primary safety endpoint due to missing the 30 day visit and no additional visits occurred beyond day 30. One subject was not evaluable for the 30 Day primary safety endpoint due to an early 30 day visit and no additional visits Day 30. These subjects were therefore not included in the denominator for the primary safety endpoint analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tack Endovascular System (4F) | Safety - Number of Participants With MALE Plus POD at 30 Days | 3 Participants |
Secondary
Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months
Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
Time frame: 6 months
Population: Some subjects had Tack implants placed in multiple lesions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tack Endovascular System (4F) | Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months | 248 number of lesions |
Secondary
Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months
Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
Time frame: 6 months
Population: The number of evaluable subjects for Target Limb Salvage at 6 Months was 209.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tack Endovascular System (4F) | Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months | 206 Participants |