Angioplasty Clinical Trial
— GAAMEOfficial 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.
Verified date | May 2009 |
Source | Neovasc Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | March 2009 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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°. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Canada | Vancouver Hospital | Vancouver | British Columbia |
Netherlands | Amphia Hospital | Breda | The Netherlands |
Netherlands | Leiden University Medical Center | Leiden | The Netherlands |
Netherlands | Medisch Centrum Rijmond Zuid | Rotterdam | The Netherlands |
Netherlands | University Medical Center Rotterdam | Rotterdam | The Netherlands |
United States | Sinai Hospital | Baltimore | Maryland |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Pasco Cardiology Center | Hudson | Florida |
United States | Baptist Miami Hospital | Miami | Florida |
United States | Columbia Presbyterian Hospital | New York | New York |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | UC Irvine Medical Center | Orange | California |
United States | Mercy Heart Institute | Sacramento | California |
United States | Florida Cardiovascular Institute | Tampa | Florida |
United States | Tyler Cardiovascular Consultants | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Neovasc Inc. |
United States, Canada, Netherlands,
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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. — View Citation
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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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To observe the safety of the device, as determined by freedom from MACE (major adverse cardiac events) within 30 days post-procedure. | 30 days | Yes | |
Primary | To observe the success of the device as determined by residual diameter stenosis | 30 days | No | |
Primary | To evaluate the inflation of dilation balloon to desired pressure | immediate | No | |
Secondary | To evaluate the successful delivery of catheter to target area | immediate | No | |
Secondary | To evaluate the performance of the device to measure arterial size | immediate | No |
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