Treatment of Patients With Lesions in the Superficial Femoral or Popliteal Arteries Using Kanshas Drug Coated Balloon (KANSHAS1)
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|ClinicalTrials.gov Identifier: NCT02939924|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Femoropopliteal Occlusive Disease Peripheral Artery Disease||Device: Kanshas DCB||Not Applicable|
The KANSHAS 1 (K-1) trial investigates the inhibition of restenosis using the Kanshas DCB in the treatment of de novo lesions in the superficial femoral or popliteal arteries.
The proposed clinical study will be a prospective, multi-center, controlled, open, single-arm study. Up to 50 patients will be enrolled at up to 7 sites in Belgium and Germany. Follow-ups are scheduled before discharge, at 30 days, 6 months, 1, and 2 years. Each patient will have a follow-up contact via hospital visit and telephone.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multi-Center, Open, Single Arm Study for the Treatment of Patients Presenting De Novo Lesions in the Superficial Femoral or Popliteal Arteries Using a Kanshas Drug Coated Balloon Catheter|
|Actual Study Start Date :||April 7, 2017|
|Actual Primary Completion Date :||July 18, 2018|
|Estimated Study Completion Date :||January 2020|
Experimental: DCB treatment
Patient treated with Kanshas DCB
Device: 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939924
|AZ Sint Blasius|
|Principal Investigator:||Michael Lichtenberg, MD||Karolinen-Hospital Klinikum Arnsberg, Germany|