NCT04737291

Brief Summary

Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

January 13, 2021

Last Update Submit

February 2, 2021

Conditions

Drug Coated Balloon

Outcome Measures

Primary Outcomes (2)

  • Freedom from device- and procedure-related mortality

    mortality related to procedure

    30 days

  • 30 days clinically driven target vessel revascularization

    patency rate

    30 days

Secondary Outcomes (2)

  • Major adverse events

    12 months

  • 1 year clinically driven target vessel revascularization

    12 months

Study Arms (1)

Angioplasty by DCB

EXPERIMENTAL

angioplasty of stenotic , ocluded or recoil segment using drug coated ballon

Device: drug coated balloon

Interventions

drug coated balloonDEVICE

use of drug coated balloon in treatment of critical limb ischemia

Angioplasty by DCB

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults at least 18 years of age with critical lower limb ischemia (Rutherford category 4, 5), stenotic (≥70% by visual angiographic assessment) or occlusive lesions in the native SFA or PPA, and vessel diameter ≥4 and ≤6 mm were eligible.
  • Total lesion length ≤190 mm (visual angiographic assessment).
  • DE novo angioplasty
  • Recurrent or recoil lesion

You may not qualify if:

  • pregnancy
  • breast feeding
  • iliac lesions
  • Malignancy
  • Patients with raised renal chemistry.
  • Patients with contraindication to antiplatelet therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • hassan bakr, professor

    Assiut University

    STUDY CHAIR

  • mahmoud ismael, ass profesor

    Assiut University

    STUDY DIRECTOR

  • osman mahmoud, lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed nageeb, master

CONTACT

01096192891a7mednageeb@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 13, 2021

First Posted

February 3, 2021

Study Start

March 15, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

February 3, 2021

Record last verified: 2021-02