Trial Outcomes & Findings for Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty (NCT NCT02758847)

Last Updated: 2024-04-25

Results Overview

Percentage of participants with wound healing defined as \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

12 months

Results posted on

2024-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Critical Limb Ischemia (CLI) and Tissue Loss n=50 Participants 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.
Age, Continuous	68.9 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Diabetes	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Percentage of participants with wound healing defined as \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.

Outcome measures

Outcome measures
Measure	Critical Limb Ischemia (CLI) and Tissue Loss n=50 Participants 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.
Wound Healing	30 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The study patients that are alive and have follow up information at 6 months

Percentage of participants with a 6 month amputation free survival.

Outcome measures

Outcome measures
Measure	Critical Limb Ischemia (CLI) and Tissue Loss n=35 Participants 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.
Amputation Free Survival	71.4 percentage of participants

SECONDARY outcome

Timeframe: 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

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)."

Outcome measures

Outcome measures
Measure	Critical Limb Ischemia (CLI) and Tissue Loss n=50 Participants 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.
Primary Patency ( Determine if Vessel Remains Open)	97 percentage of participants

Adverse Events

Critical Limb Ischemia (CLI) and Tissue Loss

Serious events: 11 serious events

Other events: 12 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Critical Limb Ischemia (CLI) and Tissue Loss n=50 participants at risk 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.
Vascular disorders Major Amputation	22.0% 11/50 • Number of events 11 • Adverse event data were collected over a 1 year period The definition of adverse events does not differ from the clinical trials.gov Definitions

Other adverse events

Other adverse events
Measure	Critical Limb Ischemia (CLI) and Tissue Loss n=50 participants at risk 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.
Infections and infestations Wound Infection	24.0% 12/50 • Number of events 12 • Adverse event data were collected over a 1 year period The definition of adverse events does not differ from the clinical trials.gov Definitions

Additional Information

Dr Rabih Chaer

University of Pittsburgh

Phone: 4128023333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place