Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial
Condition: Ischemic Heart Disease; Restenosis
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of DES have not diminished the need of improved treatment strategies , especially the
      treatment of bifurcation lesions still leave much to be clarified. Particularly, for
      bifurcation lesions where stenting the main branch could result in an obstruction of a vital
      side branch, many reports have been about using 2 drug-eluting stents. Resulting in less than
      favorable, target lesion revascularization (TLR) rates, with 10-15% for main branch and
      11-40% for side branch.

      In Japan, the PERFECT multi-center registry evaluated outcomes of single stenting plus
      kissing balloon technique after Directional Coronary Atherectomy (DCA) removal of tissue
      plaques. TLR rates for both main branch and side branch were a satisfactory 1.3%. However,
      the DCA technique is mainly suitable for proximal coronary artery lesions, and takes skilled
      operators.

      For the treatment of relatively distal bifurcation lesions, where first POBA is performed,
      then the lesion is stented, followed by kissing balloon technique to fully expand the side
      branch, is considered a viable treatment. The Toyohashi Heart Center outcomes from August
      2004 for this single stent and kissing ballooning technique, using the sirolimus-eluting
      stent on bifurcation lesions, achieved a satisfactory 5.2% TLR for both main and side
      branches, suggesting that using two stents may not be necessarily the ideal treatment.

      The paclitaxel-eluting stent is expected to become available in Japan from June 2007. This
      stent's cells can be expanded to a maximum of 3.5mm, which should provide a larger lumen
      access for side-branch treatment.

      As such, we developed this study to compare the outcomes of paclitaxel-eluting and
      sirolimus-eluting stents in bifurcation lesions that require side branch dilatation using the
      kissing ballooning technique.
    

Detailed description: 
      1. Primary Endpoints Target lesion revascularization after one year

        2. Secondary Endpoints Secondary endpoints be evaluated in terms of safety and efficacy.

      2-1 Safety

        1. Major complications associated with procedure (death, QMI, CABG)

        2. Major complications at follow-up (within 9 months) (death, QMI, CABG)

        3. Target vessel revascularization (TVR) performed within 9 months 2-2 Efficacy

      1. Acute angiographic success

        -  Minimum lumen diameter (MLD)

           ・% stenosis 2. Angiographic success at follow-up

        -  Minimum lumen diameter (MLD)

           ・% stenosis

        -  Loss index

        -  Late loss
    

Intervention name(s): Sirolimus-eluting coronary stent (Cypher); Paclitaxel-eluting stent (TAXUS)
Intervention type(s): Device; Device
Intervention description(s): Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.; Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
Intervention MeSH terms: Sirolimus; Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment