This trial is examining the effectiveness of a new drug-releasing stent, Svelte, for the treatment of coronary heart disease (CAD). The main outcome to be measured will be target lesion failure (heart attack/death due to blockage in the blood vessel that has the stent) 12 months later. This study is being conducted in the United States, Japan, and the Netherlands.
The details
Coronary artery disease (CAD) is caused by blockages in the blood vessels that supply the heart muscle. These blockages result in the heart muscle not getting enough oxygen. CAD can result in acute coronary syndrome (ACS). This includes heart attacks and unstable angina. The treatment for ACS is the placing of stents (small tubes) in the blood vessels to keep them open.
New stents are constantly being developed. Drug-releasing stents are now used. They continuously release a drug to prevent the stent from becoming blocked again. The effectiveness of stents can be evaluated through the target lesion failure (TLF). TLF is when a patient has a heart attack or dies due to a blockage in the blood vessel with the stent in it (failed stent).
This study will be evaluating the new drug-releasing stent, Svelte. The main outcome to be measured is TLF 12 months after stent placement
Who are they looking for?
This study is recruiting 1630 patients. Patients must be eligible for surgical stent insertion and must be an acceptable candidate for coronary artery bypass grafting (CABG). Patient has to have up to 3 blockages in up to 2 coronary blood vessels (no more than 2 blockages in a single blood vessel).
Patients must not be medically unstable, on life-support/ventilator, in shock. The blockage must not be in within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery or be located in a blood vessel that has already been grafted.
How will it work
Patients will be randomly assigned to one of two groups. One group will receive the Sveltestent and the other group will have a standard drug-releasing stent placed. The rates of target lesion failure will be measured within 12 months after stent placement. Patients will be followed up at 6 months, 12 months and then annually for 5 years.
