Back to results

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

Primary Purpose

Ischemia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Angiogram, Medtronic DCB (paclitaxel)/stent

Angiogram, Bard DCB (paclitaxel)/stent

About this trial

This is an interventional treatment trial for Ischemia focused on measuring critical lower limb ischemia with tissue loss

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Judith Brimmeier

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Critical Limb Ischemia (CLI) and Tissue Loss

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Amputation Free Survival

Percentage of participants with a 1 year amputation free survival.

Secondary Outcome Measures

Primary Patency ( determine if vessel remains open)

Prospective duplex ultrasound will be performed at the intervals listed to verify (primary and secondary) patency of targeted vessels. Assessment of severe restenosis and reinterventions will be determined

Rate of severe stenosis (narrowing) and reinterventions

Severe stenosis (>50%) evaluated by Duplex ultrasound at 1,3,6 and 12 month intervals

Full Information

NCT ID

NCT02758847

First Posted

April 11, 2016

Last Updated

March 2, 2023

Sponsor

Rabih A. Chaer

1. Study Identification

Unique Protocol Identification Number

NCT02758847

Brief Title

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

Official Title

Evaluation of Paclitaxel in Patients With CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 2016 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rabih A. Chaer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemia

Keywords

critical lower limb ischemia with tissue loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Critical Limb Ischemia (CLI) and Tissue Loss

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Angiogram, Medtronic DCB (paclitaxel)/stent

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Angiogram, Bard DCB (paclitaxel)/stent

Intervention Description

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 Outcome Measure Information:

Title

Wound Healing

Description

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

Title

Amputation Free Survival

Description

Percentage of participants with a 1 year amputation free survival.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Primary Patency ( determine if vessel remains open)

Description

Time Frame

3, 6, 12 months

Title

Rate of severe stenosis (narrowing) and reinterventions

Description

Severe stenosis (>50%) evaluated by Duplex ultrasound at 1,3,6 and 12 month intervals

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rabih A Chaer, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Judith Brimmeier

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15237

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

still early in the recruitment process

Learn more about this trial

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

We'll reach out to this number within 24 hrs