Coronary Bifurcation Lesions Treated With Biguard Stent System

NCT02597283 | Withdrawn DMC

• 1 other identifier: NFHMU20150902
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to test the hypothesis that the Biguard stent system will lead to fewer target lesion failure compared to regular stent system in patients with coronary bifurcation lesions at one year.

Conditions

Coronary Artery Disease

Keywords

Bifurcation lesions; Percutaneous coronary intervention; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Incidence of Ischemia Driven Target Lesion Failure (ID-TLF)

  The number of participants with adverse events that are related to treatment. Adverse events included cardiac death (death in which a cardiac cause cannot be excluded), Myocardial infarction (MI, classified as Q-wave and non-Q wave), Ischemia-driven target lesion revascularization (TLR) by CABG or PCI and Ischemia-driven target vessel revascularization (TVR) by CABG or PCI.

  12 months

Secondary Outcomes (21)

• In-stent late lumen loss in millimeter

  13 months

• Proximal Late Loss in millimeter

  13 months

• Distal Late Loss in millimeter

  13 months

• Incidence of Target Vessel Failure (TVF)

  30 days

• Incidence of Target Vessel Failure (TVF)

  1 year

Other Outcomes (2)

• Acute Success: Clinical Procedure

  7 days

• Acute Success: Clinical Device

  7 days

Study Arms (2)

Biguard stent system

EXPERIMENTAL

PCI with Biguard sirolimus-eluting bifurcation stent system

Device: Biguard sirolimus-eluting bifurcation stent system

Sirolimus-eluting stent system

ACTIVE COMPARATOR

PCI with regular sirolimus-eluting stent system

Device: Sirolimus-eluting stent system

Interventions

Biguard sirolimus-eluting bifurcation stent system DEVICE

PCI with Biguard sirolimus-eluting bifurcation stent system

Also known as: Biguard Stent System

Biguard stent system

Sirolimus-eluting stent system DEVICE

PCI with sirolimus-eluting stent system

Also known as: SES

Sirolimus-eluting stent system

Eligibility Criteria

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

You may qualify if:

• Subject must be age≥18 years;
• 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 eligible for percutaneous coronary intervention (PCI);
• Subject has symptomatic coronary artery disease or documented silent ischemia;
• Subject is willing to comply with all protocol-required follow-up evaluations;
• Target lesion must be a de novo true bifurcation lesions located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤4.00 mm;
• Target lesion must have visually estimated stenosis ≥50%;
• The lesion length of main branch vessel must measure \<40 mm, and the lesion length of side branch vessel must measure \<20 mm (by visual estimate);
• Subject with no more than one lesion existing in the same vessel can be chosen, when several bifurcation lesions existing simultaneously;
• Subject with knowledge of trial purpose, informed consents and volition of undergoing coronary angiography and clinical follow-up voluntarily.

You may not qualify if:

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI within two weeks;
• Subject is on dialysis or has serum creatinine level \>3.0 mg/dL;
• Subject has known allergy to the study stent system or protocol-required concomitant medications;
• Subject has any other serious medical illness that may reduce life expectancy to less than 12 months; Patient with cardiac heart failure (above New York Heart Association (classification) III), or left ventricular ejection fraction (LVEF)\< 30%;
• Subject with hemorrhagic tendency or history of active peptic ulcers, cerebral hemorrhage, or subarachnoid hemorrhage, cerebral stroke within half a year, as well as patients who have contraindication to anti-platelet agents or anticoagulant treatment;
• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint or intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure;
• Subject Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk- Subject has more than 1 lesion that requires treatment during the index procedure;
• Target lesion meets any of the following criteria:
• Thrombus, or possible thrombus, present in the target vessel;
• Excessive tortuosity proximal to or within the lesion;
• Excessive angulation proximal to or within the lesion;
• Chronic total occlusion lesion in target vessel not re-canalized;
• severe calcification with unsuccessfully pre-dilated;
• restenosis disease.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

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

• Shao-Liang Chen, MD

  Director of Cardiology and Cath Lab, Nanjing First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital, Nanjing Medical University

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 5, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share