An interventional study of Angiogram, Medtronic DCB (paclitaxel)/stent and Angiogram, Bard DCB (paclitaxel)/stent in Ischemia, sponsored by Rabih A. Chaer. Completed at 1 site in United States. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Rabih A. Chaer · Not applicable, Interventional, and Treatment
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.
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.
2,062 studies on the registry are indexed under Ischemia; 345 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 1,361 interventional studies indexed under Ischemia.
Browse Ischemia studies →Rabih A. Chaer is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Device: Angiogram, Medtronic DCB (paclitaxel)/stent · Device: Angiogram, Bard 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.
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.
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
Amputation Free Survival
Percentage of participants with a 6 month amputation free survival.
Time frame: 6 months
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
| Milestone | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
Percentage of participants with wound healing defined as \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.
| Participants | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Wound Healing | 30 |
Percentage of participants with a 6 month amputation free survival.
| percentage of participants | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Amputation Free Survival | 71.4 |
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)."
| percentage of participants | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Primary Patency ( Determine if Vessel Remains Open) | 97 |
Collected over Adverse event data were collected over a 1 year period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Critical Limb Ischemia (CLI) and Tissue Loss | 16/50 (32%) | 11/50 (22%) | 12/50 (24%) |
| Event | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Major AmputationVascular disorders | 11/50 |
| Event | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Wound InfectionInfections and infestations | 12/50 |
| Age, Continuous(years) | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Mean | 68.9 ± 11.0 |
| Sex: Female, Male(Participants) | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Female | 21 |
| Male | 29 |
| Race (NIH/OMB)(Participants) | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 42 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Diabetes(Participants) | Critical Limb Ischemia (CLI) and Tissue Loss |
|---|---|
| Count of participants | 38 |
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Plan to share: Undecided — still early in the recruitment process
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Rabih A. Chaer