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

Angioplasty Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399646
• Other study ID #: revJ060707
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2006
• Last updated: May 11, 2009
• Start date: November 2005
• Est. completion date: March 2009

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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°.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty

Intervention

Device:
• Metricath Gemini System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Neovasc Inc.

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

References & Publications (6)

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View 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. — View 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. — View 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. — View 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. — 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

Outcome

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