Femoropopliteal Occlusive DiseaseKANSHAS-1NCT02939924
Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.
A study testing Kanshas DCB in people with Femoropopliteal Occlusive Disease and Peripheral Artery Disease, run by Terumo Europe N.V. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal Occlusive Disease, Peripheral Artery Disease
- What is being tested?
- Kanshas DCB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Apr 2017to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- ≥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;
- Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
- Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
- 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.
- 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;
Who cannot join
- 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;
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- 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;
- Has injuries in the target vessel, such as major flow-limiting dissection ( > NHLBI Grade C) and perforation, requiring stenting prior to enrollment;
- Obvious subintimal recanalization or intentional subintimal recanalization in the occlusive lesions;
- Presence of severe calcification in the target lesions that precludes endovascular treatment. Severe calcification is defined as circumferential calcification involving ≥ 50% of vessel diameter.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
Klinikum Hochsauerland Gmbh
Arnsberg
Uni-Herzzentrum
Bad Krozingen
Ev Luth Diakonissenanstalt
Flensburg
RoMed Klinikum
Rosenheim
About this study
Official title: 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.
Read the 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.
- Being tested
- Kanshas DCB
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kanshas DCBDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DCB treatment | Experimental | Patient treated with Kanshas DCB Receives: Device: Kanshas DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start7 Apr 2017
- Primary completion18 Jul 2018
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lichtenberg, MD, Principal investigator, Karolinen-Hospital Klinikum Arnsberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939924
- Sponsor's protocol ID
- T129E4
- Acronym
- KANSHAS-1
- Status last verified
- Sep 2023
- First submitted
- 17 Oct 2016
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02939924
- Acronym / sponsor ID
- KANSHAS-1 / T129E4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB treatment | Experimental | Device: Kanshas DCBPatient treated with Kanshas DCB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kanshas DCBThe 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. | Device | DCB treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lichtenberg, MD principal investigator
Karolinen-Hospital Klinikum Arnsberg, Germany
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kanshas DCB in people with Femoropopliteal Occlusive Disease and Peripheral Artery Disease, run by Terumo Europe N.V. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.