Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.

NCT02939924 | Completed DMC

• 1 other identifier: T129E4
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 6

Brief Summary

Assessing the safety and effectiveness of the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.

Conditions

Femoropopliteal Occlusive Disease; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure of the study is a composite of freedom from device and procedure related deaths through 30 days, freedom from target limb amputation, and clinically driven target lesion revascularization (TLR) through 6 months.

  Clinically-driven target lesion revascularization is defined as a restenosis of 50% or more in the target lesion with worsening symptoms, OR more as 70% stenosis without symptoms.

  6 months

Study Arms (1)

DCB treatment

EXPERIMENTAL

Patient treated with Kanshas DCB

Device: Kanshas DCB

Interventions

Kanshas DCB DEVICE

The appropriate Kanshas DCB size is selected after review of the patient's baseline angiogram and determination of the reference vessel diameter and lesion length. The balloons is sized to ensure the full length of the lesion is treated. The initial inflation of the study device should be approximately 1 minute for optimal drug release. In order to optimize lesion dilatation, longer inflation times are possible at the discretion of the operator.

DCB treatment

Eligibility Criteria

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

You may qualify if:

• General:
• Clinically significant symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery;
• Able and willing to provide informed consent prior to study procedures;
• Able and willing to comply with follow-up requirements;
• Rutherford Clinical Category of 2-4;
• Resting ABI of \<0.9 or abnormal exercise ABI;
• ≥18 years old;
• Life expectancy is \>2 year;
• Angiographic Criteria:
• Cumulative lesion length ≥4 and ≤15 cm within the target vessel; Cumulative lesion consists of either a single de novo lesion or multiple lesions within the 4-15 cm segment; multiple lesions require to meet all the following;
• Separated by a gap of ≤ 3 cm;
• Able to be treated as a single lesion;
• Total combined lesion length including 3cm gap meets requirements;
• Lesion location starts ≥2 cm distal to the common femoral bifurcation and terminates at ≥2 cm proximal to the origin of the tibio-peroneal trunk;
• Clinically and hemodynamically significant de novo stenosis (\>70% stenosis by visual estimate) or occlusion;

You may not qualify if:

• Pregnant or lactating females;
• Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries;
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;
• Known intolerance to study medications, paclitaxel or contrast agents;
• Patient participating in another investigational device or drug study that has not reached the primary endpoint;
• History of hemorrhagic stroke within 2 months;
• Previous or planned surgical or interventional procedure within 30 days of the study procedure;
• Diagnosed liver failure, renal failure, chronic kidney disease, unstable angina pectoris, or myocardial infarction within 30 days of the procedure;
• Presence of significant stenosis or occlusion of the inflow tract that cannot be successfully treated prior to study consideration. Successful is defined as \<30% residual stenosis of ipsilateral iliac artery with no major complications;
• Acute thrombus in target vessel;
• At site of target lesion, use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, brachytherapy);
• Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥50% stenosis) may not be treated during the same procedure;
• Has in-stent restenosis in the target lesion;
• Previous treatment with a drug coated PTA balloon catheter or drug eluting stent in the target vessel within 12 months of the index procedure;
• Previous peripheral bypass affecting the target limb;

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (6)

AZ Imelda

Bonheiden, Belgium

Location

AZ Sint Blasius

Dendermonde, Belgium

Location

Klinikum Hochsauerland Gmbh

Arnsberg, Germany

Location

Uni-Herzzentrum

Bad Krozingen, Germany

Location

Ev Luth Diakonissenanstalt

Flensburg, Germany

Location

RoMed Klinikum

Rosenheim, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Michael Lichtenberg, MD

  Karolinen-Hospital Klinikum Arnsberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 20, 2016
• Study Start: April 7, 2017
• Primary Completion: July 18, 2018
• Study Completion: March 29, 2023
• Last Updated: April 23, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); BE (2)