Clinical trial NCT02597283: Coronary Bifurcation Lesions Treated With Biguard Stent System
Official title: A Prospective, Multi-center, Randomized Trial Comparing Biguard Stent With Regular Sirolimus-eluting Stent System for Patients With Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Bifurcation lesions
Percutaneous coronary intervention
Randomized controlled trial
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of Biguard bifurcation stent system and regular stent system in patients with bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure was around 12% after PCI with regular stent system. And the investigators previous data showed that this event at 12-month after Biguard bifurcation stent system was 4%. Considering the lost to follow-up, it is anticipated that up to 400 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 2 years.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

  1. Thrombus, or possible thrombus, present in the target vessel;
  2. Excessive tortuosity proximal to or within the lesion;
  3. Excessive angulation proximal to or within the lesion;
  4. Chronic total occlusion lesion in target vessel not re-canalized;
  5. severe calcification with unsuccessfully pre-dilated;
  6. restenosis disease.

Primary outcomes:
measure: Incidence of Ischemia Driven Target Lesion Failure (ID-TLF)
timeFrame: 12 months
Secondary outcomes:
measure: In-stent late lumen loss in millimeter
timeFrame: 13 months
measure: Proximal Late Loss in millimeter
timeFrame: 13 months
measure: Distal Late Loss in millimeter
timeFrame: 13 months
measure: Incidence of Target Vessel Failure (TVF)
timeFrame: 30 days
measure: Incidence of Target Vessel Failure (TVF)
timeFrame: 1 year
measure: Incidence of Target Vessel Failure (TVF)
timeFrame: 3 year
measure: Incidence of Target Vessel Failure (TVF)
timeFrame: 5 year
measure: Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 30 days
measure: Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 1 year
measure: Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 3 year
measure: Incidence of Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 5 year
measure: Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 30 days
measure: Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 1 year
measure: Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 3 year
measure: Incidence of Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 5 year
measure: Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
timeFrame: 30 days
measure: Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
timeFrame: 1 year
measure: Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
timeFrame: 3 year
measure: Incidence of Ischemia Driven Major Adverse Cardiac Event (MACE)
timeFrame: 5 year
measure: In-stent % Angiographic Binary Restenosis (% ABR) Rate
timeFrame: 13 months
measure: In-segment % Angiographic Binary Restenosis (% ABR) Rate
timeFrame: 13 months
Other outcomes:
measure: Acute Success: Clinical Procedure
timeFrame: 7 days
measure: Acute Success: Clinical Device
timeFrame: 7 days
Locations:
Study officials:
affiliation: Director of Cardiology and Cath Lab, Nanjing First Hospital
name: Shao-Liang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: