Ischemic Heart DiseaseCROSSNCT01186198
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
An observational study of Ischemic Heart Disease and Coronary Artery Stenosis, run by Abbott Medical Devices at 4 sites in United States.
Trial summary
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion
- What is being tested?
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Aug 2010to 30 Dec 2010
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be enrolled at 4 sites in the United States (US). At each site, at least two different qualified physicians will perform the index procedures. Approximately 30% of the enrolled subjects will be females.
Who may be able to join
- General Inclusion Criteria
- Subject must be at least 18 years of age.
- Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.
- Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
- Subject must have single or multiple vessel coronary artery disease with clinical evidence of myocardial ischemia (e.g., stable or unstable angina or silent ischemia documented by a positive functional study).
- Subject must be an acceptable candidate for CABG.
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- Subject must agree to undergo all protocol-required follow-up procedures.
- Subject must agree not to participate in any other clinical study during hospitalization for the index procedure.
- Angiographic Inclusion Criteria
- All angiographic inclusion criteria are based on visual estimation.
- De novo or restenotic lesions in native coronary arteries or bypass grafts.
- A maximum of two lesions, including at least one target lesion, in up to two major epicardial distribution trees. Tandem lesions, defined as multiple, focal lesions that can be covered by one stent, will be considered as a single lesion.
- If one target lesion and one non-target lesion are to be treated, the target and non-target lesions must be located in different major epicardial distribution trees.
- The target lesion must have a diameter stenosis of ≥ 70% by visual estimation or online quantitative coronary angiography (QCA), which may include chronic total occlusion (CTO).
- Lesions may be located in highly tortuous vessels.
Who cannot join
- General Exclusion Criteria
- Subject has had a known diagnosis of an acute myocardial infarction (AMI) within 72 hours preceding the intended index procedure.
- The subject is currently experiencing clinical symptoms consistent with a new onset of AMI, such as prolonged chest pain with ischemic ECG changes unresponsive to nitrates.
- Subject has hemodynamic instability or any hemodynamically unstable cardiac arrhythmias.
- Subject has a known left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
- Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
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- Subject will require Low Molecular Weight Heparin (LMWH) within 8 hours before or at any time after the index procedure.
- Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- Subject has a platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3.
- Subject has a serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
- Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
- Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Subject has had active peptic ulcer or a significant gastrointestinal or urinary bleed within the past six months.
- Elective surgery is planned during hospitalization for the index procedure that will require discontinuing dual anti-platelet therapy.
- Subject has other medical illness (e.g., cancer) that may confound the data interpretation or is associated with a limited life expectancy.
- Subject is currently participating in an investigational study when such participation could confound the treatment or outcomes of this study.
- Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Angiographic Exclusion Criteria
- All angiographic exclusion criteria are based on visual estimation.
- More than two lesions require treatment. Tandem lesions, defined as multiple, focal lesions that can be covered by one stent, will be considered as a single lesion.
- Target lesion is located in an unprotected left main artery.
- Coronary artery spasm in the absence of significant stenosis.
- Target vessel contains thrombus as indicated in the initial angiographic images.
- During the index procedure, any lesion requires additional treatment with any adjunctive or ablative device (i.e., rotational or directional atherectomy, cutting balloon, laser, thrombectomy, etc.).
- Target lesion involving a bifurcation with a side branch ≥ 2.5 mm in diameter, with an ostial lesion > 40% stenosed, or with a side branch requiring protection guide wire or pre-dilatation.
- Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Christ Hospital
Cincinnati, Ohio, 45219
Scripps Green Hospital
La Jolla, California, 92037
Northern Michigan Hospital
Petoskey, Michigan, 49770
Peninsula Regional Medical Center
Salisbury, Maryland, 21804
About this study
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Being tested
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Keywords
- Coronary Dilatation Catheter, Balloon Dilatation Catheter, Angioplasty, Myocardial Ischemia, Coronary Stenosis, Percutaneous Coronary Intervention (PCI), Percutaneous Transluminal Coronary Angioplasty (PTCA), Chronic Total Occlusion (CTO)
- Medical subject headings
- Myocardial Ischemia, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINI TREK RX 1.20 mm Coronary Dilatation CatheterDevice
Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions
| Study group | Role | What they receive |
|---|---|---|
| MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Patients requiring initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis will be included. Receives: Device: MINI TREK RX 1.20 mm Coronary Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Procedure Success
Procedure success was defined as meeting all the following after single or multiple attempts:
- Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion,
- Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon,
- No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon, and
- Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.
Measured: On Day 0 (From the start to end of the interventional procedure)
Secondary outcomes (6)
Rate of Device Success
Device Success was defined as meeting all the following after single or multiple attempts:
- Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, defined as achieving a final residual percent diameter stenosis of < 50%,
- Successful dilatation with the MINI TREK RX 1.20 mm balloon as defined by improvement in Minimal Lumen Diameter (MLD) based on core lab analysis, and
- No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias that required medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon.
Measured: On Day 0 (From the start to end of the interventional procedure)
Rate of Lesion Success
Lesion Success was defined as meeting all the following after single or multiple attempts:
- Successful dilatation with any device(s), defined as achieving a final residual percent diameter stenosis of < 50%,
- No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with any device(s), and
- Achievement of a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.
Measured: On Day 0 (From the start to end of the interventional procedure)
Rate of Individual Procedural Parameters
The following parameters were assessed by either an angiographic core laboratory or the investigator at the site
- Vessel perforation
- Flow-limiting vessel dissection
- Development of thrombus in the target vessel
- Balloon rupture
- Clinically significant arrhythmias requiring medical treatment or device intervention
Measured: On Day 0 (From the start to end of the interventional procedure)
Rate of Major Adverse Cardiac Event (MACE)
In-hospital MACE was defined as the composite of all deaths, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR) by coronary artery bypass graft surgery (CABG) or PCI during the hospitalization for the index procedure
Measured: In-Hospital (1 - 3 Days)
Rate of Target Lesion Failure (TLF)
In-hospital TLF was defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the hospitalization for the index procedure
Measured: In-Hospital (1 - 3 Days)
Rate of Stent Thrombosis
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Angiographic confirmation involves presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within 48-hours:
Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers; Non-occlusive; Occlusive thrombus
Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy is a pathological confirmation.
Probable stent thrombosis is considered to have occur after intracoronary stenting in case of any unexplained death within the first 30 days or any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Measured: In-Hospital (1 - 3 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study start12 Aug 2010
- Primary completion30 Dec 2010
- Study completion30 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David E Kandzari, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186198
- Sponsor's protocol ID
- 10-802
- Acronym
- CROSS
- Status last verified
- Jan 2023
- First submitted
- 9 Aug 2010
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kandzari DE, Teirstein PS, Kereiakes DJ, Cannon LA, Hearne SE, Kuo HC, Ying SW, Cheong WF, Popma JJ. Procedural effectiveness of a novel 1.20 mm diameter angioplasty catheter: clinical and angiographic outcomes. J Interv Cardiol. 2013 Apr;26(2):131-6. doi: 10.1111/j.1540-8183.2013.12021.x. Epub 2013 Jan 31.
PubMed 23369084