Ischemia
Conditions
Keywords
critical lower limb ischemia with tissue loss
Brief summary
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries was terminated. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss.
Detailed description
Although the association between the drug coated balloon (DCB) therapy and limb outcomes could not be clearly linked to the use of antiproliferative agents, the findings of paclitaxel crystals downstream of the treated lesions, although in small amounts, has raised concerns about the safety of such therapy in patients with critical limb ischemia (CLI) and tissue loss. These concerns, however, may not translate to patients with femoropopliteal occlusive disease as the amount of paclitaxel reaching the foot may be even smaller after being filtered by the calf musculature. Since the use of DCB angioplasty in the Superficial Femoral Artery (SFA) and popliteal has been shown to deliver significantly more durable outcomes compared to standard angioplasty alone, with reported primary patency rates of almost 90% at one year, this therapy may even be more needed in patients with tissue loss where prolonged patency is essential for wound healing.
Interventions
DEVICEAngiogram, Medtronic DCB (paclitaxel)/stent
Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Each participant will receive angiogram with DCB (drug coated balloon)/stenting with wound debridement. 50% of subjects will receive an Angiogram, Medtronic DCB (paclitaxel)/stent. Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.
DEVICEAngiogram, Bard DCB (paclitaxel)/stent
Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. 50% of subjects will receive 'Angiogram, Bard DCB (paclitaxel)/stent' . Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.
Sponsors
Rabih A. Chaer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Patient population: all patients with CLI (critical limb ischemia) and tissue loss scheduled for endovascular intervention for femoral popliteal occlusive or multilevel disease. * Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form * Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation * Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 5 or 6 * General Angiographic Inclusion Criteria * Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in the SFA and/or popliteal arteries. * Iliac inflow or Tibial outflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)
Exclusion criteria
* Patient unwilling or unlikely to comply with Follow-Up schedule * Aneurysm in the target vessel * Acute thrombus in the target limb * Sensitivity to Paclitaxel * Immunosuppressed patients (transplant, chemotherapy, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | 12 months | Percentage of participants with wound healing defined as \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year. |
| Amputation Free Survival | 6 months | Percentage of participants with a 6 month amputation free survival. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency ( Determine if Vessel Remains Open) | 6 months | Prospective duplex ultrasound will be performed at the listed interval to verify (primary and secondary) patency of targeted vessels. Primary patency is defined as the target vessel patency obtained without the need for additional or secondary surgical or endovascular procedures (the interval from the time of the original intervention until any intervention designed to maintain or re-establish patency is performed). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Critical Limb Ischemia (CLI) and Tissue Loss Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Patients with CLI will receive either Angiogram, Medtronic DCB (paclitaxel)/stent or Angiogram, Bard DCB (paclitaxel)/stent
Angiogram, Medtronic DCB (paclitaxel)/stent: Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Each participant will receive angiogram with DCB (drug coated balloon)/stenting with wound debridement. 50% of subjects will receive an Angiogram, Medtronic DCB (paclitaxel)/stent. Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.
Angiogram, Bard DCB (paclitaxel)/stent: Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. 50% of subjects will receive 'Angiogram, Bard DCB (paclitaxel)/stent' . Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 11 |
| Diabetes | 38 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 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 | 42 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 50 |
| other Total, other adverse events | 12 / 50 |
| serious Total, serious adverse events | 11 / 50 |
Outcome results
Primary
Amputation Free Survival
Percentage of participants with a 6 month amputation free survival.
Time frame: 6 months
Population: The study patients that are alive and have follow up information at 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Critical Limb Ischemia (CLI) and Tissue Loss | Amputation Free Survival | 71.4 percentage of participants |
Primary
Wound Healing
Percentage of participants with wound healing defined as \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.
Time frame: 12 months
Population: 50 consecutive patients with documented Rutherford Category 5 or 6 chronic limb threatening ischemia (CLTI) in the target limb were prospectively enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Critical Limb Ischemia (CLI) and Tissue Loss | Wound Healing | 30 Participants |
Secondary
Primary Patency ( Determine if Vessel Remains Open)
Prospective duplex ultrasound will be performed at the listed interval to verify (primary and secondary) patency of targeted vessels. Primary patency is defined as the target vessel patency obtained without the need for additional or secondary surgical or endovascular procedures (the interval from the time of the original intervention until any intervention designed to maintain or re-establish patency is performed).
Time frame: 6 months
Population: 50 consecutive patients with documented Rutherford Category 5 or 6 chronic limb threatening ischemia (CLTI) in the target limb were prospectively enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Critical Limb Ischemia (CLI) and Tissue Loss | Primary Patency ( Determine if Vessel Remains Open) | 97 percentage of participants |