Conventional Versus Intentional StraTegy in Lesions With High Risk PrEdiction of Side Branch OccLusion in InterVEntion

NCT02644434 | Unknown DMC

• 1 other identifier: China_NCCD
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to investigate if intentional strategy (a more aggressive side branch protection strategy: elective two-stent or jailed balloon technique) is associated with significant reduction of side branch occlusion rate compared to conventional strategy (provisional two-stent strategy or jailed wire technique) in patients at high risk of side branch occlusion (V-RESOLVE score≥12).

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Coronary Bifurcation Intervention; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• side branch occlusion after main vessel stenting

  The primary endpoint is side branch occlusion, which is defined as any decrease in TIMI flow grade or absence of flow in side branch after main vessel stent well opposed.

  Immediately after the main vessel

Secondary Outcomes (2)

• The elevation of biomarkers of peri-procedural myocardial injury (Creatine Kinase-Myocardial Band (CK-MB) and Troponin I)

  48h after Percutaneous Coronary Intervention (PCI)

• Major adverse cardiac events (MACE)

  12-month

Study Arms (2)

Conventional Strategy

ACTIVE COMPARATOR

Patients randomized to the conventional strategy group would undergo either jailed wire technique (diameter of side branch\<2.5mm and ≥2.0mm) or provisional two-stent strategy (diameter of side branch≥2.5mm).

Procedure: Conventional Strategy

Intentional Strategy

EXPERIMENTAL

Patients randomized to the intentional strategy group would undergo either jailed balloon technique (diameter of side branch\<2.5mm and ≥2.0mm) or elective two-stent strategy (diameter of side branch≥2.5mm).

Procedure: Intentional strategy

Interventions

Conventional Strategy PROCEDURE

Jailed wire technique: Both MV and SB are wired. The MV is stented with wire protection in SB. The SB is not further treated unless there is threatened SB closure, severe ostial pinching of SB (\>90%), TIMI flow grade decrease in SB, or SB dissection greater than type A. If one of these criteria exists, the SB would be rewired and a kissing balloon inflation is undertaken. Provisional two-stent strategy: Lesion preparation and MV stenting are the same as the jailed wire technique. Provisional T stenting of the SB could be undertaken if one of the following criteria exists after SB rewiring and a kissing balloon inflation is undertaken: threatened SB closure, severe ostial pinching of SB (\>90%), TIMI flow grade decrease in SB, or SB dissection greater than type A.

Conventional Strategy

Intentional strategy PROCEDURE

Jailed balloon technique: The technique has been detailed in previous studies. A monorail balloon that is angiographically sized to approximate the Side Branch (SB) vessel diameter is advanced into the SB. If there is TIMI flow grade decrease in the SB after MV stenting, the SB balloon is inflated to simulate attempt to reopen the SB. The procedure would be completed with the standard kissing balloon technique no matter there is SB compromise or not. Elective two-stent strategy: Patients in this subgroup would undergo crush procedure or any other elective two-stent strategy which stenting SB before MV stenting.

Intentional Strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be male or nonpregnant female ≥18 years of age and ≤75 years of age;
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
• Subject is eligible for PCI;
• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
• Subject is willing to comply with all protocol-required follow-up evaluation.
• Subjects have coronary bifurcation lesions requiring PCI with stent implantation according to clinical guidelines and/or the operator's judgement;
• Visually estimated reference vessel diameter (RVD) of target main vessel ≥2.5 mm and ≤4.0 mm;
• Visually estimated RVD of target side branch ≥ 2.0mm;
• Coronary anatomy is likely to allow delivery of a study device to the target lesion(s);
• V-RESOLVE score ≥ 12 points.

You may not qualify if:

• Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or the trial stent system or protocol-required concomitant medications (e.g., stent alloy, stainless steel, sirolimus, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin);
• Planned surgery within 6 months after the index procedure;
• Subject has one of the following (as assessed prior to the index procedure):
• Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months；
• Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.);
• Planned procedure that may cause non-compliance with the protocol or confound data interpretation;
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions;
• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint;
• Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure;
• Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure);
• Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential);
• Subject with left ventricular ejection fraction \< 35%;
• Subject has preoperative renal dysfunction: serum creatinine\>2.0mg/dl (176.82umol/L).
• Left main lesions;
• In case of acute myocardial infarction of which the culprit vessel located at the left anterior descending (LAD) artery, the bifurcation lesion (LAD/diagonal branch \[RVD\>2.5mm\]) which is proximal to occluded LAD segment should be excluded.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (18)

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  PMID: 25616816 BACKGROUND

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• Dou K, Zhang D, Xu B, Yang Y, Yin D, Qiao S, Wu Y, Yan H, You S, Wang Y, Wu Z, Gao R, Kirtane AJ. An angiographic tool for risk prediction of side branch occlusion in coronary bifurcation intervention: the RESOLVE score system (Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):39-46. doi: 10.1016/j.jcin.2014.08.011.

  PMID: 25616815 RESULT

• Zhang D, Zhao Z, Gao G, Xu H, Wang H, Liu S, Yin D, Feng L, Zhu C, Wang Y, Zhao Y, Yang Y, Gao R, Xu B, Dou K. Jailed Balloon Technique Is Superior to Jailed Wire Technique in Reducing the Rate of Side Branch Occlusion: Subgroup Analysis of the Conventional Versus Intentional StraTegy in Patients With High Risk PrEdiction of Side Branch OccLusion in Coronary Bifurcation InterVEntion Trial. Front Cardiovasc Med. 2022 Mar 31;9:814873. doi: 10.3389/fcvm.2022.814873. eCollection 2022.

  PMID: 35433861 DERIVED

• Dou K, Zhang D, Pan H, Guo N, Li L, Li Y, Zhang Q, Liu B, Shen Z, Zhang B, Liu J, Han W, Wang Y, Zhao Y, Yang Y, Chen S, Xie L, Guan C, Kirtane AJ, Xu B; CIT-RESOLVE Investigators. Active SB-P Versus Conventional Approach to the Protection of High-Risk Side Branches: The CIT-RESOLVE Trial. JACC Cardiovasc Interv. 2020 May 11;13(9):1112-1122. doi: 10.1016/j.jcin.2020.01.233.

  PMID: 32381188 DERIVED

• Zhang D, Yin D, Song C, Zhu C, Kirtane AJ, Xu B, Dou K. A randomised comparison of Conventional versus Intentional straTegy in patients with high Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion: rationale and design of the CIT-RESOLVE trial. BMJ Open. 2017 Jun 12;7(6):e016044. doi: 10.1136/bmjopen-2017-016044.

  PMID: 28606906 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Kefei Dou, MD, PhD

  Fuwai Hospital and National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Bo Xu, MBBS

  Fuwai Hospital and National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Zhang, MD

CONTACT

+86-18810488380; pumczhangdong@126.com

Chenxi Song, MD

CONTACT

+86-18810991570; 1933769555@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

CN (1)