Coronary Artery DiseasePhase 4CROSSNCT00694005
Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch
A Phase 4 study testing kissing balloon and without kissing balloon angioplasty "leave alone" in people with Coronary Artery Disease, run by Seung-Jung Park at 11 sites in South Korea.
Trial summary
Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- kissing balloon and without kissing balloon angioplasty "leave alone"
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Jan 2008to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si
Busan Saint Mary's Hospital
Busan
Cheongju Saint Mary's Hospital
Cheongju-si
Chungnam National University Hospital
Daejeon
Kyungsang University Hospital
Jinju
Hallym University Sacred Heart Hospital
Pyeongchon
Catholic University, Kangnam St. Mary's Hospital
Seoul
Hallym University Sacred Heart Hospital
Seoul
Aju University Hospital
Suwon
Ulsan University Hospital
Ulsan
Kangwon University Hospital
Wŏnju
About this study
Official title: Phase IV Study of the 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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- kissing balloon, without kissing balloon angioplasty "leave alone"
- Keywords
- stent, bifurcation, balloon angioplasty
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kissing balloonProcedure or surgery
Also called Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
without kissing balloon angioplasty "leave alone"Procedure or surgery
Also called sirolimus, zotarolimus, paclitaxel, and everolimus stents
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
| Study group | Role | What they receive |
|---|---|---|
| bifurcation stent techniqe | Active comparator | cross over stenting without kissing balloon angioplasty "leave alone" Receives: Procedure: without kissing balloon angioplasty "leave alone" |
| bifurcation stent technique | Experimental | kissing balloon angioplasty Receives: Procedure: kissing balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
8 month after PCI
Measured: 8 months
Secondary outcomes (13)
Incidence of side branch jail after main vessel stenting according to the stent type used
Day 1 (24 hours after the index procedure)
Measured: Day 1
Angiographic reocclusion rate of side branch
8month after PCI
Measured: 8 months
Angiographic restenosis rate of side branch and the main vessel
8month after PCI
Measured: 8 months
Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure
8month after PCI
Measured: 8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type
8month after PCI
Measured: 8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type
8month after PCI
Measured: 8 months
Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization
Measured: 2 years
FFR of the side branch at post-procedure and at follow-up
Day 1 (immediately after the index procedure)and 8month after PCI
Measured: Day 1, 8 months
Incidence of peri-procedural cardiac enzyme elevation
Day 1 (24 hours after the index procedure)
Measured: Day 1
Fluoroscopic time
Day 1 (immediately after the index procedure)
Measured: Day 1
Procedure time
Day 1 (immediately after the index procedure)
Measured: Day 1
Amount of contrast agent
Day 1 (immediately after the index procedure)
Measured: Day 1
Number of used stents
Day 1 (immediately after the index procedure)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694005
- Sponsor's protocol ID
- 2008-0185
- Acronym
- CROSS
- Status last verified
- Nov 2015
- First submitted
- 5 Jun 2008
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch
- ClinicalTrials.gov ID
- NCT00694005
- Acronym / sponsor ID
- CROSS / 2008-0185
- Conditions
- Coronary Artery Disease
- Keywords
- stent, bifurcation, balloon angioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Jan 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bifurcation stent techniqe | Active comparator | Procedure: without kissing balloon angioplasty "leave alone"cross over stenting without kissing balloon angioplasty "leave alone" |
| bifurcation stent technique | Experimental | Procedure: kissing balloonkissing balloon angioplasty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical
- Angiographic
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kissing balloonAlso: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stentssimultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions | Procedure or surgery | bifurcation stent technique |
| without kissing balloon angioplasty "leave alone"Also: sirolimus, zotarolimus, paclitaxel, and everolimus stentssimultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions | Procedure or surgery | bifurcation stent techniqe |
Primary outcome
Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy
Time frame: 8 months
8 month after PCI
13 secondary outcomes
Incidence of side branch jail after main vessel stenting according to the stent type used
Time frame: Day 1
Angiographic reocclusion rate of side branch
Time frame: 8 months
Angiographic restenosis rate of side branch and the main vessel
Time frame: 8 months
Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure
Time frame: 8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type
Time frame: 8 months
Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type
Time frame: 8 months
Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization
Time frame: 2 years
FFR of the side branch at post-procedure and at follow-up
Time frame: Day 1, 8 months
Incidence of peri-procedural cardiac enzyme elevation
Time frame: Day 1
Fluoroscopic time
Time frame: Day 1
Procedure time
Time frame: Day 1
Amount of contrast agent
Time frame: Day 1
Number of used stents
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jung Park, MD, PhD principal investigator
Asan Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing kissing balloon and without kissing balloon angioplasty "leave alone" in people with Coronary Artery Disease, run by Seung-Jung Park at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.