Evaluation of the Metricath Gemini System, a Device Intended to Make Arterial Measurements and Perform Angioplasty Dilations. (GAAME)

This study has been completed.
Sponsor:
Information provided by:
Neovasc Inc.
ClinicalTrials.gov Identifier:
NCT00399646
First received: November 14, 2006
Last updated: May 11, 2009
Last verified: May 2009
  Purpose

The purpose of the Metricath Gemini System is to pre-dilate the target treatment area, take arterial lumen measurements in a native section of artery or within the deployed stent and perform further dilation of the deployed stent if required. In this manner, the Metricath Gemini System can assist the Interventionalist by providing arterial measurements prior to stenting, performing pre-stenting angioplasty, taking within stent measurements to help determine if the stent is fully deployed, and by performing post-stenting dilations to further dilate the stent if required.


Condition Intervention Phase
Angioplasty
Device: Metricath Gemini System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gemini Angioplasty and Arterial Measurement Evaluation (GAAME) An Evaluation of the Metricath Gemini System, a Percutaneous Interventional Device Intended to Make Arterial Lumen Measurements and Perform Percutaneous Transluminal Angioplasty Dilations.

Resource links provided by NLM:


Further study details as provided by Neovasc Inc.:

Primary Outcome Measures:
  • To observe the safety of the device, as determined by freedom from MACE (major adverse cardiac events) within 30 days post-procedure. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • To observe the success of the device as determined by residual diameter stenosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • To evaluate the inflation of dilation balloon to desired pressure [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the successful delivery of catheter to target area [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • To evaluate the performance of the device to measure arterial size [ Time Frame: immediate ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Several recent clinical studies have suggested that proper vascular stent deployment directly affects clinical outcome, and the rate of re-stenosis. These studies suggest that angiography alone is not sufficient to ensure proper vascular stent deployment, and that re-stenosis rates will decline if proper stent apposition has occurred. The importance of proper stent sizing and apposition is further emphasised with the increasing use of drug eluting stents, the drug effects of which are only realized upon contact with the arterial wall.

Angiometrx Inc. developed the Metricath Arterial Measurement System in response to the need for increased stent sizing and deployment. The Metricath System measures the diameter and cross sectional area of arteries using an intravascular balloon catheter attached to a computerized console. Considering the ease and rapidity of obtaining Metricath results, this technique may form an alternative to evaluate vessel area and stent expansion.

The Metricath System was 510(k) cleared in the U.S. in June, 2003, and received European and Canadian market approvals in 2004.

Angiometrx Inc. has now developed the next generation of Metricath System, which incorporates a second balloon on the catheter, intended for angioplasty purposes. The Metricath Gemini System is comprised of a dual balloon catheter which is attached to the same Metricath computerized console as the Metricath System. As with the Metricath System, the Metricath Console operates the inflation and deflation of the Gemini measurement balloon and provides arterial cross-sectional area and diameter. The Metricath Gemini angioplasty balloon is controlled separately in the traditional manner using a hand-held inflation device, attached to a port in the hub of the catheter.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in whom coronary artery angiography is indicated and angioplasty and stenting is being considered.
  • Single vessel disease of an artery with a lesion assessable to standard coronary guidewires and are scheduled or indicated for percutaneous coronary intervention.
  • A maximum of one lesion requiring treatment (angioplasty +/- stenting) to an intended arterial diameter of 2.5 mm - 4.0 mm.
  • Target stent length of 15 mm - 32 mm, where a single stent can adequately cover the lesion.
  • Stenotic de novo lesions in native coronary arteries.

Exclusion Criteria:

  • Women who are pregnant.
  • Participation in a study involving investigational drugs or devices during the last six months.
  • Patients with previous stenting in the target vessel area.
  • Patients who experienced a myocardial infarction, Braunwald Class C, and very unstable Braunwald Class B3 within 6 weeks prior to the procedure or have unstable angina pectoris.
  • Patients who are experiencing TIA's or minor or major strokes within six months prior to procedure.
  • Contraindicated for antiplatelet and/or anticoagulation medications.
  • Symptoms of cardiogenic shock.
  • Patients who underwent a staged procedure 30 days prior to enrolment and/or were scheduled to have a staged procedure 14 days after treatment.
  • Significant liver or kidney disease or malignancy.
  • Patients scheduled for any other surgery or other procedure within 30 days.
  • Severe peripheral vascular disease preventing femoral access.
  • Left ventricle ejection fraction of < 35%.
  • Total occlusion of target vessel.
  • A blood pressure in excess of 180 mmHg at the time of the angiography.
  • Visible thrombus, filling defect, or ulceration in the target artery.
  • Severely calcified lesions which suggest that balloon pre-dilatation will not achieve adequate luminal diameter to allow successful stent delivery and deployment.
  • The target lesion is beyond a left main artery stenosis > 50%.
  • Contraindicated for CABG.
  • Coronary spasm in the absence of a significant stenosis.
  • Requiring treatment of more than two lesions.
  • Requiring treatment with atherectomy.
  • Lesions in surgical conduits - saphenous vein grafts, internal mammary arteries, or radial arteries.
  • Unprotected left main coronary artery.
  • Diffuse disease.
  • Excessive tortuosity of proximal segment.
  • Extremely angulated segments > 90°.
  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: NCT00399646

Locations
United States, California
UC Irvine Medical Center
Orange, California, United States, 92868-4080
Mercy Heart Institute
Sacramento, California, United States, 95819-3633
United States, Florida
Pasco Cardiology Center
Hudson, Florida, United States, 34667
Baptist Miami Hospital
Miami, Florida, United States, 33176
Florida Cardiovascular Institute
Tampa, Florida, United States, 33609
United States, Maryland
Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Tyler Cardiovascular Consultants
Tyler, Texas, United States, 75701
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Vancouver Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Netherlands
Amphia Hospital
Breda, The Netherlands, Netherlands
Leiden University Medical Center
Leiden, The Netherlands, Netherlands
University Medical Center Rotterdam
Rotterdam, The Netherlands, Netherlands
Medisch Centrum Rijmond Zuid
Rotterdam, The Netherlands, Netherlands
Sponsors and Collaborators
Neovasc Inc.
Investigators
Principal Investigator: Willem van der Giessen, MD Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands
Principal Investigator: Evelyn Regar, MD Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands
Principal Investigator: David Kandzari, MD Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, USA
  More Information

Publications:
Cannon CP, Battler A, Brindis RG, Cox JL, Ellis SG, Every NR, Flaherty JT, Harrington RA, Krumholz HM, Simoons ML, Van De Werf FJ, Weintraub WS, Mitchell KR, Morrisson SL, Brindis RG, Anderson HV, Cannom DS, Chitwood WR, Cigarroa JE, Collins-Nakai RL, Ellis SG, Gibbons RJ, Grover FL, Heidenreich PA, Khandheria BK, Knoebel SB, Krumholz HL, Malenka DJ, Mark DB, Mckay CR, Passamani ER, Radford MJ, Riner RN, Schwartz JB, Shaw RE, Shemin RJ, Van Fossen DB, Verrier ED, Watkins MW, Phoubandith DR, Furnelli T. American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol. 2001 Dec;38(7):2114-30. No abstract available.
Smith SC Jr, Dove JT, Jacobs AK, Kennedy JW, Kereiakes D, Kern MJ, Kuntz RE, Popma JJ, Schaff HV, Williams DO, Gibbons RJ, Alpert JP, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association task force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty); Society for Cardiac Angiography and Interventions. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)-executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions. Circulation. 2001 Jun 19;103(24):3019-41. No abstract available.
van der Geissen WJ, Regar E, McFadden E, McDougall I, Serruys PW. Assessment of stent dimensions with a novel intracoronary balloon-based system: comparative study versus intravascular ultrasound and quantitative coronary angiography. The CAMUS - Coronary Angioplasty Metricath vs. ultrasound trial. EuroIntervention 1: 244-251, 2005.

Responsible Party: Fabio De Pasquale, Regulatory Afairs Director, Neovasc, Inc.
ClinicalTrials.gov Identifier: NCT00399646     History of Changes
Other Study ID Numbers: revJ060707
Study First Received: November 14, 2006
Last Updated: May 11, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014