NCT00399646

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 13, 2009

Status Verified

May 1, 2009

Enrollment Period

2 years

First QC Date

November 14, 2006

Last Update Submit

May 11, 2009

Conditions

Angioplasty

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • To evaluate the successful delivery of catheter to target area

    immediate

  • To evaluate the performance of the device to measure arterial size

    immediate

Interventions

Metricath Gemini SystemDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

UC Irvine Medical Center

Orange, California, 92868-4080, United States

Location

Mercy Heart Institute

Sacramento, California, 95819-3633, United States

Location

Pasco Cardiology Center

Hudson, Florida, 34667, United States

Location

Baptist Miami Hospital

Miami, Florida, 33176, United States

Location

Florida Cardiovascular Institute

Tampa, Florida, 33609, United States

Location

Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Columbia Presbyterian Hospital

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Tyler Cardiovascular Consultants

Tyler, Texas, 75701, United States

Location

Vancouver Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

Amphia Hospital

Breda, The Netherlands, Netherlands

Location

Leiden University Medical Center

Leiden, The Netherlands, Netherlands

Location

Medisch Centrum Rijmond Zuid

Rotterdam, The Netherlands, Netherlands

Location

University Medical Center Rotterdam

Rotterdam, The Netherlands, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 9740343BACKGROUND

  • 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.

    PMID: 10920064BACKGROUND

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

    PMID: 2868172BACKGROUND

  • 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.

    PMID: 11738323BACKGROUND

  • 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.

    PMID: 11413094BACKGROUND

  • 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.

    PMID: 19758910BACKGROUND

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 15, 2006

Study Start

November 1, 2005

Primary Completion

November 1, 2007

Study Completion

March 1, 2009

Last Updated

May 13, 2009

Record last verified: 2009-05

Locations

CA(2)US(10)NL(4)