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Completed

NCT Number: NCT00694005

Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch

Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunhyang University Bucheon Hospital, Bucheon-si, South Korea

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About this study

Among the bifurcation type, bifurcation lesion without significant side branch stenosis (<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissection, thrombosis formation, embolization of plaque debris, ostial compromise by displaced stent strut, and snow plow effect, the side branch might be compromised. In this situation, the strategy to achieve optimal results has not been reported. Recently, FFR study showed that most jailed side branch (vessel size >2.0 mm. DS>50%) after main branch stenting did not have functional significance. We compared strategies with or without routine kissing balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with serial change of FFR measurement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical
  • Patients with angina and documented ischemia or patients with documented silent ischemia
  • Patients who are eligible for intracoronary stenting
  • Age >18 years, <75 ages
  • Angiographic
  • De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0
  • Main vessel : >= 2.5 mm in vessel size, >= 50% in diameter stenosis and =< 50 mm in lesion length by visual estimation, in which the lesion is covered with =< 2 stents
  • Side branch :>= 2.0 mm in vessel size and < 50% diameter stenosis by visual estimation

Exclusion criteria

  • History of bleeding diathesis or coagulopathy
  • Pregnant
  • Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus, paclitaxel and zotarolimus
  • Limited life-expectancy (less than 1 year) due to combined serious disease
  • ST-elevation acute myocardial infarction =< 2 weeks
  • Characteristics of lesion:
  • Left main disease
  • In-stent restenosis
  • Graft vessels
  • TIMI flow =< grade 2 in the side branch
  • Chronic total occlusion
  • Renal dysfunction, creatinine >= 2.0mg/dL
  • Contraindication to aspirin, clopidogrel or cilostazol

Treatment and study plan

kissing balloon

Procedure

simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions

Other names: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents

without kissing balloon angioplasty "leave alone"

Procedure

simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions

Other names: sirolimus, zotarolimus, paclitaxel, and everolimus stents

Primary outcomes

  1. Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy

    Time frame: 8 months

    8 month after PCI

Secondary outcomes

  1. Incidence of side branch jail after main vessel stenting according to the stent type used

    Time frame: Day 1

    Day 1 (24 hours after the index procedure)

  2. Angiographic reocclusion rate of side branch

    Time frame: 8 months

    8month after PCI

  3. Angiographic restenosis rate of side branch and the main vessel

    Time frame: 8 months

    8month after PCI

  4. Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure

    Time frame: 8 months

    8month after PCI

  5. Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type

    Time frame: 8 months

    8month after PCI

  6. Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type

    Time frame: 8 months

    8month after PCI

  7. Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization

    Time frame: 2 years

  8. FFR of the side branch at post-procedure and at follow-up

    Time frame: Day 1, 8 months

    Day 1 (immediately after the index procedure)and 8month after PCI

  9. Incidence of peri-procedural cardiac enzyme elevation

    Time frame: Day 1

    Day 1 (24 hours after the index procedure)

  10. Fluoroscopic time

    Time frame: Day 1

    Day 1 (immediately after the index procedure)

  11. Procedure time

    Time frame: Day 1

    Day 1 (immediately after the index procedure)

  12. Amount of contrast agent

    Time frame: Day 1

    Day 1 (immediately after the index procedure)

  13. Number of used stents

    Time frame: Day 1

    Day 1 (immediately after the index procedure)

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch

Acronym: CROSS

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2008
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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