Status:
COMPLETED
Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA)- Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease
Lead Sponsor:
Concept Medical Inc.
Conditions:
Peripheral Artery Disease
Atherosclerosis
Eligibility:
All Genders
21+ years
Brief Summary
This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better art...
Detailed Description
It is imperative to have effective treatment strategies for PAD which can maintain the patency of arteries. The current standard of care for PAD is angioplasty which includes usage of drug coated ball...
Eligibility Criteria
Inclusion
- Age ≥ 21 years or minimum age
- Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
- Lesion(s) in the infrainguinal arteries between 3 to 6mm which are suitable for endovascular treatment treated with the Xtreme Touch - Neo sirolimus PTA balloon catheter. For below the knee (BTK) arteries, lesions located in the proximal 200mm of the artery.
Exclusion
- Life expectancy ≤ 1 year
- Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
- Subject is pregnant or planning to become pregnant during the course of the study
- Failure to achieve less than 30% residual stenosis in pre-existing lesion after plain balloon angioplasty
- Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations
Key Trial Info
Start Date :
November 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04368091
Start Date
November 21 2018
End Date
December 30 2021
Last Update
March 9 2022
Active Locations (1)
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1
Sengkang General Hospital
Singapore, Singapore, 544886