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

Primary Purpose

Angioplasty

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Metricath Gemini System
Sponsored by
Neovasc Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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°.

Sites / Locations

  • UC Irvine Medical Center
  • Mercy Heart Institute
  • Pasco Cardiology Center
  • Baptist Miami Hospital
  • Florida Cardiovascular Institute
  • Sinai Hospital
  • Columbia Presbyterian Hospital
  • Duke University Medical Center
  • University of Oklahoma
  • Tyler Cardiovascular Consultants
  • Vancouver Hospital
  • St. Paul's Hospital
  • Amphia Hospital
  • Leiden University Medical Center
  • Medisch Centrum Rijmond Zuid
  • University Medical Center Rotterdam

Outcomes

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.
To observe the success of the device as determined by residual diameter stenosis
To evaluate the inflation of dilation balloon to desired pressure

Secondary Outcome Measures

To evaluate the successful delivery of catheter to target area
To evaluate the performance of the device to measure arterial size

Full Information

First Posted
November 14, 2006
Last Updated
May 11, 2009
Sponsor
Neovasc Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00399646
Brief Title
Evaluation of the Metricath Gemini System, a Device Intended to Make Arterial Measurements and Perform Angioplasty Dilations.
Acronym
GAAME
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neovasc Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Metricath Gemini System
Primary Outcome Measure Information:
Title
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
Title
To observe the success of the device as determined by residual diameter stenosis
Time Frame
30 days
Title
To evaluate the inflation of dilation balloon to desired pressure
Time Frame
immediate
Secondary Outcome Measure Information:
Title
To evaluate the successful delivery of catheter to target area
Time Frame
immediate
Title
To evaluate the performance of the device to measure arterial size
Time Frame
immediate

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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°.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem van der Giessen, MD
Organizational Affiliation
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evelyn Regar, MD
Organizational Affiliation
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Kandzari, MD
Organizational Affiliation
Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-4080
Country
United States
Facility Name
Mercy Heart Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95819-3633
Country
United States
Facility Name
Pasco Cardiology Center
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Baptist Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Cardiovascular Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Columbia Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Tyler Cardiovascular Consultants
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Vancouver Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
Amphia Hospital
City
Breda
State/Province
The Netherlands
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
The Netherlands
Country
Netherlands
Facility Name
Medisch Centrum Rijmond Zuid
City
Rotterdam
State/Province
The Netherlands
Country
Netherlands
Facility Name
University Medical Center Rotterdam
City
Rotterdam
State/Province
The Netherlands
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
9740343
Citation
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.
Results Reference
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PubMed Identifier
10920064
Citation
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.
Results Reference
background
PubMed Identifier
2868172
Citation
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Results Reference
background
PubMed Identifier
11738323
Citation
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.
Results Reference
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PubMed Identifier
11413094
Citation
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.
Results Reference
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PubMed Identifier
19758910
Citation
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.
Results Reference
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Evaluation of the Metricath Gemini System, a Device Intended to Make Arterial Measurements and Perform Angioplasty Dilations.

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