Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Balloon angioplasty; Procedure: Stent implantation

• Registration Number: NCT01278186
• Lead Sponsor: B.Braun Surgical SA

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel-eluting balloon	Balloon angioplasty	Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun)
Paclitaxel-eluting stent	Stent implantation	Paclitaxel-eluting stent

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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-

Trial Locations

Locations (9)

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Universitario Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitari Son Dureta; 🇪🇸 Palma de Mallorca, Illes Balears, Spain

Hospital Universitario de Puerto Real; 🇪🇸 Puerto Real, Cadiz, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital Universitario Puerta del Mar; 🇪🇸 Cadiz, Spain

Complejo Hospitalario San Pedro de Alcantara; 🇪🇸 Caceres, Spain