KISS version 2.0 dated 01 July 2020
Research type
Research Study
Full title
KISS Study (Keep bIfurcation Single stenting Simple)
IRAS ID
282687
Contact name
Mohaned Egred
Contact email
Sponsor organisation
CERIC
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 2 days
Research summary
Coronary bifurcation lesions are lesions that occur at or near segment where the vessel splits in two: a main vessel and a side vessel (vessels supplying blood to the heart). Their treatment is a complex intervention although relying on angioplasty, a technique routinely used by interventional cardiologists. With similar therapies, while bifurcation lesions represent 15 to 20% of coronary angioplasties, those procedures are associated to lower success rates and increased complications occurrences.
Although the technique is used daily in the routine practice, there is still place for improvements in the treatment of bifurcation lesions because both vessels need to be treated. The treatment in the main vessel is to place a stent (a tiny expandable wire-mesh tube) to re-expand the narrowed area in the main vessel and improve blood flow to the heart. Two approaches exist to treat the side vessel: to open it with a balloon or not.
While the benefit of stenting in the main vessel is confirmed, the debate is still there around the added value of side vessel treatment. Thus, the role of side vessel intervention remains unclear. Pros and cons of those two techniques on side vessel are debated by experts.
The purpose of the study is to determine the best way of treating a bifurcation lesion. During the angioplasty, a stent will be implanted in the main vessel. Then, two methods of treatment in the side vessel will be compared:
- Use an inflatable balloon to open the side vessel
- Or leave the side vessel with no intervention at all.
Patients will be allocated in one of these two methods. The aim of the study is to find which method is best.
The KISS study will include 596 subjects at about 20 sites in England, France, Spain, Italy, Portugal, and Switzerland, of whom 60 patients in England.
The total duration of the study is 47 months. The participation duration for each patient is 12 months, with follow-up visits at 1 month and 12 months.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/LO/0596
Date of REC Opinion
16 Nov 2021
REC opinion
Further Information Favourable Opinion