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

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.

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.

Study Overview

• Status: Completed
• Conditions: Angioplasty
• Intervention / Treatment: Device: Metricath Gemini System

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.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Vancouver Hospital
• Netherlands
  • The Netherlands
    • Breda, The Netherlands, Netherlands
      • Amphia Hospital
    • Leiden, The Netherlands, Netherlands
      • Leiden University Medical Center
    • Rotterdam, The Netherlands, Netherlands
      • Medisch Centrum Rijmond Zuid
    • Rotterdam, The Netherlands, Netherlands
      • University Medical Center Rotterdam
• United States
  • California
    • Orange, California, United States, 92868-4080
      • UC Irvine Medical Center
    • Sacramento, California, United States, 95819-3633
      • Mercy Heart Institute
  • Florida
    • Hudson, Florida, United States, 34667
      • Pasco Cardiology Center
    • Miami, Florida, United States, 33176
      • Baptist Miami Hospital
    • Tampa, Florida, United States, 33609
      • Florida Cardiovascular Institute
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia Presbyterian Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Texas
    • Tyler, Texas, United States, 75701
      • Tyler Cardiovascular Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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°.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To observe the safety of the device, as determined by freedom from MACE (major adverse cardiac events) within 30 days post-procedure.	30 days
To observe the success of the device as determined by residual diameter stenosis	30 days
To evaluate the inflation of dilation balloon to desired pressure	immediate

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the successful delivery of catheter to target area	immediate
To evaluate the performance of the device to measure arterial size	immediate

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
• 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. doi: 10.1161/01.cir.103.24.3019. No abstract available.
• de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, van Es GA. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study). Eur Heart J. 1998 Aug;19(8):1214-23. doi: 10.1053/euhj.1998.1012.
• 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. doi: 10.1016/s0735-1097(01)01702-8. No abstract available.
• Fitzgerald PJ, Oshima A, Hayase M, Metz JA, Bailey SR, Baim DS, Cleman MW, Deutsch E, Diver DJ, Leon MB, Moses JW, Oesterle SN, Overlie PA, Pepine CJ, Safian RD, Shani J, Simonton CA, Smalling RW, Teirstein PS, Zidar JP, Yeung AC, Kuntz RE, Yock PG. Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study. Circulation. 2000 Aug 1;102(5):523-30. doi: 10.1161/01.cir.102.5.523.
• van der Giessen 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. 2005 Aug;1(2):244-51.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: November 14, 2006
• First Submitted That Met QC Criteria: November 14, 2006
• First Posted (Estimate): November 15, 2006

Study Record Updates

• Last Update Posted (Estimate): May 13, 2009
• Last Update Submitted That Met QC Criteria: May 11, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: revJ060707