ILLUMENATE BTK Post Market Study
Research type
Research Study
Full title
Prospective, Multi-center study to Evaluate Treatment of subjects with Occlusive Disease with a Novel Paclitaxel-Coated Angioplasty Balloon in below the knee (BTK) arteries: a post market clinical study
IRAS ID
236054
Contact name
Shaida Nadeem
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 18 days
Research summary
Research Summary
This is a Prospective, multi-center, single arm post market study that will be conducted in Europe.
Up to 75 subjects in up to 10 centers in Europe will be registered in the study.Summary & Purpose: Blood vessels can sometimes narrow or close-off, stopping a normal amount of blood from
flowing through the blood vessels. When this occurs and if the narrowing is severe enough, one can experience pain in the legs at rest. In some cases, a balloon catheter can be used to open up or widen the narrowed blood vessels. A balloon catheter is made up of a small balloon attached to the end of a thin tube. The physician can insert this balloon catheter into the blood vessel where the narrowing or closure is located. The balloon can then be opened (inflated) in order to decrease the narrowing which in turn increases the blood flow. This is called balloon angioplasty.
Spectranetics has developed the stellarex balloon catheter that is the same shape and size to other balloon catheters except that the balloon is coated with a drug called paclitaxel.
Paclitaxel is a well-known drug that is currently used to treat different conditions, such as some types of cancer. Paclitaxel is also used as a coating on stents, or wire mesh devices that hold open narrowed blood vessels. These paclitaxel coated stents are used in blood vessels in the heart and abdomen.
The purpose of this research is to obtain additional data to further test the balloon’s safety and performance of the stellarex balloon.The subject will need to visit 30 days, 6, 12, and 24 months post- index procedure.
Lay summary of study results
The study demonstrated that the Stellarex™ 0.014” Over the Wire (OTW) Drug-coated Angioplasty Balloon for the treatment of lesions in the popliteal and infra-popliteal native arteries is safe and effective.
This study showed a high primary efficacy rate with acceptable safety rates with no new risks identified from this study.
The use of the Stellarex™ 0.014” Over the Wire (OTW) Drug-coated Angioplasty Balloon may provide a benefit to patients.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0159
Date of REC Opinion
3 Aug 2018
REC opinion
Further Information Favourable Opinion