CAD
Conditions
Brief summary
To assess the safety and efficacy of the BridgePoint CTO system in recanalization of CTO lesions which are resistant to a conventional wire approach in a multicenter study in Chinese population
Detailed description
All subjects who are candidates for percutaneous coronary intervention (PCI), signed the informed consent form and had chronic total coronary occlusion (CTO) lesion will be evaluated for enrollment in this study.At least 100 subjects will be enrolled. Each site will be allowed to enroll up to a maximum of 25 subjects. Primary Effectiveness Endpoint: Technical Success: the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a CTO lesion in the true vessel lumen/within the collaterals in those cases that were otherwise refractory to treatment with a currently marketed guidewire Primary Safety Endpoint: 30-day MACE rate for CTO cases in which the BridgePoint Medical System was used. MACE is defined as the composite of cardiac death, Q-wave and non-Q-wave myocardial infarction(MI), and any ischemia-driven target lesion revascularization(TLR).
Interventions
OTHERsingle-arm study
single-arm study
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be ≥ 18 but \< 80 years of age * 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 myocardial infraction (MI) with objective evidence of ischemia or silent ischemia * Subject is an acceptable candidate for coronary artery bypass grafting (CABG) * Subject is willing to comply with all protocol-required follow-up evaluation * Subject has a left ventricular ejection fraction (LVEF) ≥45% as measured within 60 days prior to enrollment Angiographic Inclusion Criteria: AI1. A maximum of one de novo CTO lesion in a native coronary artery with thrombolysis in Myocardial Infarction (TIMI) flow grade 0 AI2. Non-acute CTO lesion with an estimated duration of at least 3 months by clinical history and/or comparison with previous angiogram or electrocardiogram(ECG) AI3. The CTO lesion must have an angiographic landing zone≥ 10 mm proximal to any major bifurcation without severe calcification. AI4. Lesion length \< 40mm without excessive tortuosity and angulation(\>45°)
Exclusion criteria
* Subject has clinical symptoms and/or ECG changes consistent with Acute MI (include STEMI and Non- STEMI) within 1 week * Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina * Subject has received an organ transplant or is on a waiting list for an organ transplant * Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure * Planned PCI (including staged procedures) or CABG after the index procedure * Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or protocol-required concomitant medications (e.g., aspirin or all thienopyridines) * 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 is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) * Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant. * Subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dL (177µmol/L) * Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions * Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months * Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding * Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) or LVEF \< 45% at the time of the index procedure * 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 had PCI within the previous 2 weeks * 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) Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the Collaterals | Subject follow up will occur via telephone contact or clinic visit at 30 days,6 and 12 months post index procedure. | 6 subjects have the results data, and 5 of them (83.3%) reported technical success. One (16.7%) failed. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CTO BridgePoint System BridgePoint CTO System:
* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire single-arm study: single-arm study | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 8 of the 20 subjects already enrolled were unable to complete the the 12-month follow-up | 8 |
Baseline characteristics
| Characteristic | CTO BridgePoint System | — |
|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 9.4 | — |
| Current anginal status None | 6 Participants | — |
| Current anginal status Stable angina | 5 Participants | — |
| Current anginal status Unknown | 1 Participants | — |
| Current anginal status Unstable angina | 8 Participants | — |
| Current diabetes mellitus No | 16 Participants | — |
| Current diabetes mellitus Yes | 4 Participants | — |
| Does Subject have silent ischemia No | 20 Participants | — |
| Does Subject have silent ischemia Yes | 0 Participants | — |
| Family history of coronary artery disease No | 16 Participants | — |
| Family history of coronary artery disease Unknown | 1 Participants | — |
| Family history of coronary artery disease Yes | 3 Participants | — |
| History of arrhythmia No | 19 Participants | — |
| History of arrhythmia Yes | 1 Participants | — |
| History of cardiogenic shock No | 20 Participants | — |
| History of cardiogenic shock Yes | 0 Participants | — |
| History of congestive heart failure No | 20 Participants | — |
| History of congestive heart failure Yes | 0 Participants | — |
| History of Coronary Artery Bypass Graft (CABG) surgery No | 19 Participants | — |
| History of Coronary Artery Bypass Graft (CABG) surgery Unknown | 1 Participants | — |
| History of Coronary Artery Bypass Graft (CABG) surgery Yes | 0 Participants | — |
| History of hyperlipidemia requiring medication No | 2 Participants | — |
| History of hyperlipidemia requiring medication Yes | 18 Participants | — |
| History of hypertension requiring medication No | 11 Participants | — |
| History of hypertension requiring medication Yes | 9 Participants | — |
| History of Myocardial Infarction (MI) No | 17 Participants | — |
| History of Myocardial Infarction (MI) Yes | 3 Participants | — |
| History of Percutaneous Coronary Intervention (PCI) No | 12 Participants | — |
| History of Percutaneous Coronary Intervention (PCI) Yes | 8 Participants | — |
| Left Ventricular Ejection Fraction (LVEF) measured No | 1 Participants | — |
| Left Ventricular Ejection Fraction (LVEF) measured Yes | 19 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 4 / 20 |
Outcome results
Primary
Technical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the Collaterals
6 subjects have the results data, and 5 of them (83.3%) reported technical success. One (16.7%) failed.
Time frame: Subject follow up will occur via telephone contact or clinic visit at 30 days,6 and 12 months post index procedure.
Population: Only 6 subjects have the results of technical success or not.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CTO BridgePoint System | Technical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the Collaterals | Success | 5 Participants |
| CTO BridgePoint System | Technical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the Collaterals | Failed | 1 Participants |