Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.

NCT04365075 | Unknown

• 1 other identifier: XuanwuH202001
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

Conditions

Critical Limb Ischemia; Infrapopliteal Lesions

Keywords

Excimer Laser; Angioplasty; drug-coated baloons

Outcome Measures

Primary Outcomes (1)

• Target lesion revascularization rate

  Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination.

  6-months

Secondary Outcomes (8)

• Incidence of major adverse events

  6-months

• Major amputation rate

  6-months

• Mortality

  6-months

• Ankle Brachial Index

  6-months

• transcutaneous oxygen pressure

  6-months

Study Arms (2)

Excimer Laser Combined with DCB

EXPERIMENTAL

Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.

Device: Excimer Laser Combined with DCB

Angioplasty Alone

ACTIVE COMPARATOR

Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.

Device: Angioplasty Alone

Interventions

Excimer Laser Combined with DCB DEVICE

Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.

Excimer Laser Combined with DCB

Angioplasty Alone DEVICE

Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.

Angioplasty Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The treatment vessel is DeNovo
• Stenotic (\>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
• Reference target vessel diameter between 2-4.0 mm by visual assessment
• Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
• The patient must be \>18 years of age
• Life-expectancy of more than 12 months
• The patient has no child bearing potential or negative serum pregnancy test
• within 7 days of the index procedure
• The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
• The patient must provide written patient informed consent that is approved by the ethics committee
• All inflow lesions successfully (\<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
• At least one angiographically visible target at the ankle for establishment of straight line flow.

You may not qualify if:

• Patient refusing treatment
• The target vessel segment diameter is not suitable for available catheter design.
• Unsuccessfully treated endovascular or bypass( \>30% residual stenosis) proximal ( iliac, superficial femoral, popliteal) inflow limiting arterial/graft stenosis
• Lesion lies within or adjacent to an aneurysm
• The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
• The patient has a history of prior life-threatening contrast media reaction.
• The patient is currently enrolled in another investigational device or drug trial.
• The patient is currently breast-feeding, pregnant or intends to become pregnant.
• The patient is unable to provide informed consent
• The patient has end stage renal disease (currently on any form of dialysis)
• Known Left Ventricular Ejection Fraction \< 35%
• The patient has had a myocardial ischemia within 30 days prior to enrollment
• The patient has had a cardiovascular accident within 90 days prior to enrollment
• Serum Creatinine \> 150 µmol
• The patient has a previous bypass in the target limb

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Yongquan Gu

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

jianming guo, M.D.

CONTACT

13146369562; guojianming@aliyun.com

yongquan gu, M.D.

CONTACT

15901598209; gu15901598209@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)