Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter. (KANSHAS-1)

November 14, 2022 updated by: Terumo Europe N.V.

Prospective, Multi-Center, Open, Single Arm Study for the Treatment of Patients Presenting De Novo Lesions in the Superficial Femoral and/or Popliteal Arteries Using a Kanshas Drug Coated Balloon Catheter.

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

The KANSHAS 1 (K-1) trial investigates the inhibition of restenosis using the Kanshas Paclitaxel-coated Balloon Catheter in the treatment of de novo lesions in the superficial femoral and/or popliteal arteries.

This clinical study is a prospective, multi-center, open, single-arm study. Up to 50 patients will be enrolled at 2 sites in Belgium and 4 sites in Germany. Follow-ups are scheduled before discharge, at 1 month (Clinic Visit or Phone FU), 6 months, 1-year, 2-years (Clinic Visits), 3-, 4- and 5- years (Clinic Visits or Phone FU).

Primary outcome measure:

  • freedom from device-and procedure-related death through 30 days.
  • freedom from target limb amputations and clinically driven target lesion revascularization through 6 months.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bonheiden, Belgium
        • AZ Imelda
      • Dendermonde, Belgium
        • AZ Sint Blasius
      • Arnsberg, Germany
        • Klinikum Hochsauerland GmbH
      • Bad Krozingen, Germany
        • Uni-Herzzentrum
      • Flensburg, Germany
        • Ev Luth Diakonissenanstalt
      • Rosenheim, Germany
        • RoMed Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

General:

  1. Clinically significant symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery;
  2. Able and willing to provide informed consent prior to study procedures;
  3. Able and willing to comply with follow-up requirements;
  4. Rutherford Clinical Category of 2-4;
  5. Resting ABI of <0.9 or abnormal exercise ABI;
  6. ≥18 years old;
  7. Life expectancy is >2 year;

    Angiographic Criteria:

  8. 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;
  9. 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;
  10. Clinically and hemodynamically significant de novo stenosis (>70% stenosis by visual estimate) or occlusion;
  11. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
  12. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
  13. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of ipsilateral iliac lesions); NOTE: Successful ipsilateral iliac artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
  14. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized;

Exclusion Criteria:

  1. Pregnant or lactating females;
  2. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries;
  3. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;
  4. Known intolerance to study medications, paclitaxel or contrast agents;
  5. Patient participating in another investigational device or drug study that has not reached the primary endpoint;
  6. History of hemorrhagic stroke within 2 months;
  7. Previous or planned surgical or interventional procedure within 30 days of the study procedure;
  8. Diagnosed liver failure, renal failure, chronic kidney disease, unstable angina pectoris, or myocardial infarction within 30 days of the procedure;
  9. 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;
  10. Acute thrombus in target vessel;
  11. At site of target lesion, use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, brachytherapy);
  12. Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥50% stenosis) may not be treated during the same procedure;
  13. Has in-stent restenosis in the target lesion;
  14. Previous treatment with a drug coated PTA balloon catheter or drug eluting stent in the target vessel within 12 months of the index procedure;
  15. Previous peripheral bypass affecting the target limb;
  16. Has injuries in the target vessel, such as major flow-limiting dissection ( > NHLBI Grade C) and perforation, requiring stenting prior to enrollment;
  17. Obvious subintimal recanalization or intentional subintimal recanalization in the occlusive lesions;
  18. Presence of severe calcification in the target lesions that precludes endovascular treatment. Severe calcification is defined as circumferential calcification involving ≥ 50% of vessel diameter.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DCB treatment
Patient treated with Kanshas DCB
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael Lichtenberg, MD, Karolinen-Hospital Klinikum Arnsberg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 7, 2017

Primary Completion (ACTUAL)

July 18, 2018

Study Completion (ANTICIPATED)

February 23, 2023

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (ESTIMATE)

October 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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