Drug Coated Ballon in Critical Limb Ischemia | NCT04737291

Studies
Drug Coated Ballon in Critical Limb Ischemia

NCT04737291

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 3, 2021Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Drug Coated Balloon

Interventions

drug coated balloon

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2021Estimated

Primary Completion Date

Mar 2022Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Jan 13, 2021

First Submission Date that Met QC Criteria

Feb 2, 2021

First Posted Date

Feb 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2021

Last Update Posted Date

Feb 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Mohamed Nageeb, doctor, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Critical limb ischemia (CLI) is the most advanced stage of peripheral artery disease (PAD); which is estimated to affect more than 200 million people worldwide.(1) CLI classified as Rutherford category (RC) 4-6, includes ischemic rest pain and tissue loss.(2) The first line revascularization strategy for patients with CLI is endovascular percutaneous transluminal angioplasty (PTA).(3) The treatment of femoropopliteal lesions displays a huge anatomic challenge as this segment serves various biomechanical functions, Which makes endovascular treatment is challenging.(4) Plain balloon (PB) angioplasty for femoropopliteal artery disease has a high rate of procedural success and an acceptable safety profile, in spite of initially encouraging technical success after femoropopliteal (PTA), postprocedural restenosis remains the major challenge(5) Excessive extracellular matrix material synthesized by activated smooth muscle cells (SMC) in the media of the arteries leads to Neointimal hyperplasia and restenosis.(6) Restenosis resulting in loss of primary patency, late lumen loss (LLL), occlusion and/or the need for target lesion revascularization (TLR).(7) Drug-coated balloons (DCBs) inhibit the neointimal hyperplasia, the biological mechanism of restenosis formation, by application of cytostatic agents in a local therapeutic concentration.(8) The antiproliferative paclitaxel (PTX) seems to be the most effective therapeutic agent for DCBs due to local retention in the arterial wall.(9)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Angioplasty by DCB	Experimental	angioplasty of stenotic , ocluded or recoil segment using drug coated ballon	Device: drug coated balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
drug coated balloon	Device	use of drug coated balloon in treatment of critical limb ischemia	Angioplasty by DCB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Major adverse events	major adverse events as amputation	12 months
1 year clinically driven target vessel revascularization	patency rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ahmed nageeb, master	Contact	01096192891		a7mednageeb@aun.edu.eg

Overall Officials

Name	Affiliation	Role
hassan bakr, professor	Assiut University	Study Chair
mahmoud ismael, ass profesor	Assiut University	Study Director
osman mahmoud, lecturer

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided