Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch (CROSS)
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Purpose
Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Procedure: kissing balloon Procedure: without kissing balloon angioplasty "leave alone" |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch |
- Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy [ Time Frame: 8 months ] [ Designated as safety issue: No ]8 month after PCI
- Incidence of side branch jail after main vessel stenting according to the stent type used [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Day 1 (24 hours after the index procedure)
- Angiographic reocclusion rate of side branch [ Time Frame: 8 months ] [ Designated as safety issue: No ]8month after PCI
- Angiographic restenosis rate of side branch and the main vessel [ Time Frame: 8 months ] [ Designated as safety issue: No ]8month after PCI
- Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure [ Time Frame: 8 months ] [ Designated as safety issue: No ]8month after PCI
- Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type [ Time Frame: 8 months ] [ Designated as safety issue: No ]8month after PCI
- Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type [ Time Frame: 8 months ] [ Designated as safety issue: No ]8month after PCI
- Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]12month after PCI
- FFR of the side branch at post-procedure and at follow-up [ Time Frame: Day 1, 8 months ] [ Designated as safety issue: No ]Day 1 (immediately after the index procedure)and 8month after PCI
- Incidence of peri-procedural cardiac enzyme elevation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Day 1 (24 hours after the index procedure)
- Fluoroscopic time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Day 1 (immediately after the index procedure)
- Procedure time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Day 1 (immediately after the index procedure)
- Amount of contrast agent [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Day 1 (immediately after the index procedure)
- Number of used stents [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Day 1 (immediately after the index procedure)
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: bifurcation stent techniqe
cross over stenting without kissing balloon angioplasty "leave alone"
|
Procedure: without kissing balloon angioplasty "leave alone"
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Other Name: sirolimus, zotarolimus, paclitaxel, and everolimus stents
|
|
Experimental: bifurcation stent technique
kissing balloon angioplasty
|
Procedure: kissing balloon
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Other Name: Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Young-Hak Kim, MD, PhD | 82-2-3010-3955 | mdyhkim@amc.seoul.kr |
| Contact: Duk-Woo Park, MD | 82-2-3010-3995 | parkdukwoo@hanmail.net |
| Korea, Republic of | |
| Soonchunhyang University Bucheon Hospital | Recruiting |
| Bucheon, Korea, Republic of | |
| Contact: Nae-Hee Lee naeheelee@naver.com | |
| Busan Saint Mary's Hospital | Recruiting |
| Busan, Korea, Republic of | |
| Contact: Jae-Sik Jang jsjang@medimail.co.kr | |
| Cheongju Saint Mary's Hospital | Recruiting |
| Cheongju, Korea, Republic of | |
| Contact: Yong-Mo Yang ymyang67@yahoo.co.kr | |
| Chungnam National University Hospital | Recruiting |
| Daejeon, Korea, Republic of | |
| Contact: In-Whan Seong iwseong@cnu.ac.kr | |
| Kyungsang University Hospital | Recruiting |
| Jinju, Korea, Republic of | |
| Contact: Bong-Ryong Choi choibr7@naver.com | |
| Hallym University Sacred Heart Hospital | Recruiting |
| PyeongChon, Korea, Republic of | |
| Contact: Young-Jin Choi cyj@hallym.ac.kr | |
| Hallym University Sacred Heart Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Min-Gyu Kim cagkim@hanmail.net | |
| Catholic University, Kangnam St. Mary's Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Ki-Bae Seung kbseung@catholic.ac.kr | |
| Aju University Hospital | Recruiting |
| Suwon, Korea, Republic of | |
| Contact: Seung-Jea Tahk, MD, PhD sjtahk@ajou.ac.kr | |
| Principal Investigator: Seung-Jea Tahk, MD | |
| Ulsan University Hospital | Recruiting |
| Ulsan, Korea, Republic of | |
| Contact: Sang-Gon Lee sglee@uuh.ulsan.kr | |
| Kangwon University Hospital | Recruiting |
| Wonju, Korea, Republic of | |
| Contact: Bong-Ki Lee nicedr@nate.com | |
| Principal Investigator: | Seung-Jung Park, MD, PhD | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea |
| ClinicalTrials.gov Identifier: | NCT00694005 History of Changes |
| Other Study ID Numbers: | 2008-0185 |
| Study First Received: | June 5, 2008 |
| Last Updated: | August 6, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by CardioVascular Research Foundation, Korea:
|
stent bifurcation balloon angioplasty |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus Everolimus Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013