A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions (CROSS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01186198
First received: August 9, 2010
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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 descriptive purposes only.


Condition Intervention Phase
Ischemic Heart Disease
Coronary Artery Stenosis
Chronic Coronary Total Occlusion
Coronary Bypass Graft Stenosis
Device: MINI TREK RX 1.20 mm Coronary Dilatation Catheter
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Procedure Success [ Time Frame: From the start to end of the interventional procedure ] [ Designated as safety issue: Yes ]
    1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion,
    2. Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon,
    3. 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
    4. Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.


Secondary Outcome Measures:
  • Device Success [ Time Frame: From the start to end of the interventional procedure ] [ Designated as safety issue: Yes ]
    1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion,
    2. Successful dilatation with the MINI TREK RX 1.20 mm balloon, and
    3. 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.

  • Lesion Success [ Time Frame: From the start to end of the interventional procedure ] [ Designated as safety issue: Yes ]
    1. Successful dilatation with any device(s),
    2. 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
    3. Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.

  • Individual Procedural Parameters [ Time Frame: From the start to end of the interventional procedure ] [ Designated as safety issue: Yes ]
    • Vessel perforation
    • Flow-limiting vessel dissection
    • Development of thrombus in the target vessel
    • Balloon rupture
    • Clinically significant arrhythmias requiring medical treatment or device intervention

  • Major Adverse Cardiac Event (MACE) [ Time Frame: 1 - 3 Days ] [ Designated as safety issue: Yes ]
    A 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

  • Target Lesion Failure (TLF) [ Time Frame: 1 - 3 Days ] [ Designated as safety issue: Yes ]
    A composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the hospitalization for the index procedure

  • Stent Thrombosis [ Time Frame: 1 - 3 Days ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MINI TREK RX 1.20 mm Coronary Dilatation Catheter Device: MINI TREK RX 1.20 mm Coronary Dilatation Catheter
Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions

Detailed Description:

CAUTION: Investigational device limited by Federal (U.S.) law to investigational use only

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Up to 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.

Criteria

Inclusion Criteria:

General Inclusion Criteria

  1. Subject must be at least 18 years of age.
  2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.
  3. Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
  4. 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).
  5. Subject must be an acceptable candidate for CABG.
  6. Subject must agree to undergo all protocol-required follow-up procedures.
  7. 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.

  1. De novo or restenotic lesions in native coronary arteries or bypass grafts.
  2. 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.
  3. 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.
  4. 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).
  5. Lesions may be located in highly tortuous vessels.

Exclusion Criteria:

General Exclusion Criteria

  1. Subject has had a known diagnosis of an acute myocardial infarction (AMI) within 72 hours preceding the intended index procedure.
  2. 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.
  3. Subject has hemodynamic instability or any hemodynamically unstable cardiac arrhythmias.
  4. 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).
  5. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
  6. Subject will require Low Molecular Weight Heparin (LMWH) within 8 hours before or at any time after the index procedure.
  7. 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.
  8. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  9. Subject has a serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
  10. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
  11. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  12. Subject has had active peptic ulcer or a significant gastrointestinal or urinary bleed within the past six months.
  13. Elective surgery is planned during hospitalization for the index procedure that will require discontinuing dual anti-platelet therapy.
  14. Subject has other medical illness (e.g., cancer) that may confound the data interpretation or is associated with a limited life expectancy.
  15. Subject is currently participating in an investigational study that may confound the treatment or outcomes of this study.
  16. 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.

  1. 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.
  2. Target lesion is located in an unprotected left main artery.
  3. Coronary artery spasm in the absence of significant stenosis.
  4. Target vessel contains thrombus as indicated in the initial angiographic images.
  5. 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.).
  6. 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.
  7. Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186198

Locations
United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
United States, Maryland
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21804
United States, Michigan
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: David E Kandzari, MD Piedmont Heart Hospital
  More Information

No publications provided by Abbott Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01186198     History of Changes
Other Study ID Numbers: 10-802
Study First Received: August 9, 2010
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Coronary Dilatation Catheter
Balloon Dilatation Catheter
Predilatation Balloon
Angioplasty
Myocardial Ischemia
Coronary Stenosis
PCI
PTCA
CTO

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Dilatation, Pathologic
Heart Diseases
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014