Coronary Artery Disease
Conditions
Keywords
Coronary stenosis, Bifurcation, Drug-eluting balloon, Drug-eluting stent, Angiographic follow-up, Late Lumen Loss, Restenosis
Brief summary
This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of provisional stenting with the paclitaxel-eluting stent in the main branch.
Detailed description
The bifurcated coronary lesions are still a challenge for interventional cardiologists, since there is no suitable technique or strategy to manage such lesions. This multicenter randomized prospective trial in bifurcated coronary lesions will compare the new technology of the paclitaxel-eluting balloon with the until now gold standard technique of the provisional stenting with the paclitaxel DES in the main branch.
Interventions
PROCEDUREBalloon angioplasty
Coronary angioplasty using the paclitaxel-coated balloon catheter
PROCEDUREStent implantation
Coronary angioplasty using the paclitaxel-eluting stent
Sponsors
Hospital Universitario Infanta Cristina de Badajoz
B.Braun Surgical SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
PATIENTS * Patients with stable angina (1-3) or unstable angina (1-3 A-C) or documented silent ischemia * Patients with mental and logistic conditions for the follow-up * Patients should accept an angiographic follow-up at 9 months, a clinical follow-up at 3 years and sign the consent LESIONS * De-novo lesions in the bifurcations of DA/Diag either CX/OM or CD/DP with diameters in the main vessel of 2,5 to 3,8/ 2 to 3,5 and lengths \< 22 mm * The left main lesions in bifurcation are also accepted but with another independent randomization list (specify at randomization) * The diameter of the stenoses should be \>50% in any branch with documented ischemia or more than 70% in absence of an ischemia test * Single vessel or multivessel disease * In case of a PTCA of more than one lesion, the non included lesion should be treated previously to the included lesion
Exclusion criteria
PATIENTS * Patients with STEMI \< 72 hours * Patients with congestive heart failure or NYHA IV, shock or severe valvular heart disease * Patients with short life expectancy, or with problems for platelet antiaggregation * Patients in treatment with hyperthyroidism, in treatment with immunosuppression or anticoagulants, or with alcohol or drug addiction * Patients included in other trials * Patients with a stroke 6 months before * Patients with a surgery one week before * Severe renal failure calculated as GF \< 30 ml/min Cockcroft Gault * Women of childbearing age, with probability to become pregnant during the first year of follow-up LESIONS * Evidence of important thrombus within the vessel to treat * Patients with another stent previously implanted at ≤ 15 mm from the current lesion of the study * Lesions affecting bypass * Chronic occlusions to treat * Restenosis in-stent or of a segment in 4 mm close to the target lesion * Severe calcification not totally dilatable with the balloon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss (LLL) | Late angiographic follow-up (9 months) | Assessment of the difference between both groups regarding the Late Lumen Loss (LLL) in main vessel and side branch, measured at late angiographic follow-up at 9 months |
| Restenosis | Late angiographic follow-up (9 months) | Assessment of the difference between both groups regarding the Restenosis in both branches (proximal part of the main vessel, distal part of the main vessel and side branch), measured at late angiographic follow-up at 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombosis rate | Late angiographic follow-up (9 months) | Assesment of the thrombosis rate |
| Target Lesion Revascularization (TLR) | Late angiographic follow-up (9 months) | Assessment of the Target Lesion Revascularization (TLR) at late angiographic follow-up (9 months) if dilatation by restenosis or previous angiography due to angina |
| Major Adverse Cardiac Events (MACE) | Late angiographic follow-up (9 months) | Assessment of the rate of Major Adverse Cardiac Events (MACE): death, AMI, Target Lesion Revascularization (TLR) - due to angina pectoris or angiographic restenosis- |
Countries
Spain
Outcome results
None listed