Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II)

July 14, 2023 updated by: Abbott Medical Devices

Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)

This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects will be treated with the orbital atherectomy system and adjunctive stent. All subjects will be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call or clinical follow up at each anniversary until study is closed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

443

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Trinity Hospital
      • Montgomery, Alabama, United States, 36116
        • Baptist Montgomery South
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Mercy Gilbert
    • California
      • Beverly Hills, California, United States, 90210
        • Cedar Sinai Los Angeles
      • Los Angeles, California, United States, 90017
        • Good Samaritan Hospital
      • Palm Springs, California, United States, 92270
        • Eisenhower Medical Center
      • Rancho Mirage, California, United States, 92270
        • Desert Cardiology Center
      • Sacramento, California, United States, 95825
        • Sutter Memorial Hospital
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Florida Hospital Memorial
      • Gainesville, Florida, United States, 32614
        • North Florida Regional
      • Ocala, Florida, United States, 34471
        • Munroe Regional Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital
      • Orlando, Florida, United States, 32806
        • Orlando Regional
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Gardens
      • Winter Haven, Florida, United States, 33881
        • Winter Haven
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Indiana Heart Hospital
      • Indianapolis, Indiana, United States, 46290
        • Saint Vincents Indianapolis
      • Munster, Indiana, United States, 46321
        • Community Hospital
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • King's Daughters / Kentucky Heart Foundation
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Research Institute
    • Michigan
      • Detroit, Michigan, United States, 48201-2018
        • Detroit Medical Center
      • Detroit, Michigan, United States, 48236
        • St. John's Hospital
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern
      • Saint Paul, Minnesota, United States, 55102
        • United Heart & Vascular
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michaels
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital
    • New York
      • Brooklyn, New York, United States, 71878
        • New York Methodist Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10075
        • Lenox Hill
      • Roslyn, New York, United States, 11576
        • St. Francis
    • Ohio
      • Dayton, Ohio, United States, 45405
        • Good Samaritan Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • The Heart and Vascular Center
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr / Lankenau
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary's
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital-DeSoto
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor
      • Houston, Texas, United States, 77030
        • Memorial Hermann
      • Houston, Texas, United States, 77030
        • St. Luke's
    • Utah
      • Layton, Utah, United States, 84041
        • Davis Hospital
    • Washington
      • Bellingham, Washington, United States, 98225
        • Saint Joe Bellingham / North Cascade Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects must be 18 or older.
  • Subjects must have a clinical indication for coronary intervention.
  • CK and CK-MB must be less than or equal to the upper limit of lab normal value within 8 hours prior to the procedure.
  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.
  • The target vessel must be a native coronary artery with a stenosis of >= 70% and < 100%.
  • The target vessel reference diameter must be >= 2.5mm and <= 4.0 mm.
  • The lesion length must not exceed 40 mm.
  • The target vessel must have a TIMI flow 3 at baseline.
  • The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion.
  • The lesion must be crossable with the study guide wire.

Exclusion Criteria:

  • Inability to understand the study or a history of non-compliance with medical advice.
  • Unwilling or unable to sign the ORBIT II Informed Consent Form (ICF).
  • History of any cognitive or mental health status that would interfere with study participation.
  • Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.).
  • Female subjects who are pregnant or planning to become pregnant within the study period.
  • Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications.
  • Known sensitivity to contrast media, which cannot be adequately pre-medicated.
  • Diagnosed with chronic renal failure or has a serum creatinine level >2.5 mg/dl.
  • Experienced acute MI (STEMI or non-STEMI: CK and CK-MB greater than 1 times the upper limit of lab normal) within 30 days prior to index procedure.
  • History of major cardiovascular intervention within 30 days.
  • Evidence of current (within 6 months) left ventricular ejection fraction ≤ 25%.
  • NYHA class III or IV heart failure.
  • History of a stroke or transient ischemic attack (TIA) within 6 months.
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months.
  • History of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • History of immune deficiency.
  • Uncontrolled insulin dependent diabetes.
  • Evidence of active infections on the day of the index procedure.
  • Subject has planned cardiovascular intervention within 60-days post index procedure.
  • Subject is not an acceptable candidate for emergent coronary artery bypass surgery.
  • Subject with known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
  • Subject with 3 lesions requiring intervention.
  • Subject with 2 lesions unless the treatment of the lesions is staged. The non target lesion must first be treated at least 12 hours prior to the index procedure. The subject's CK and CK-MB must be less than or equal to one times the upper limit of the lab normal value 12 ± 2 hours post procedure and there were no procedural complications during the first lesion intervention.
  • Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass.
  • Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate or on-line QCA.
  • Target vessel has angiographically visible or suspected thrombus.
  • Target vessel has a stent from previous PCI.
  • Target vessel is excessively tortuous.
  • Target lesion is an ostial location (within 5 mm of ostium) or an unprotected left main lesion.
  • Target lesion is a bifurcation.
  • Target lesion has a ≥ 1.5 mm side branch.
  • Angiographic evidence of a dissection prior to OAS treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
Time Frame: 30 days

OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of:

  • Cardiac death.
  • MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave.
  • TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
30 days
Primary Efficacy Endpoint: Procedural Success
Time Frame: Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.
Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.
Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic Success
Time Frame: Baseline procedure, with a mean total procedure time of 52.5 minutes.
Angiographic success was defined as success in facilitating stent delivery with <50% residual stenosis and without severe angiographic complications.
Baseline procedure, with a mean total procedure time of 52.5 minutes.
Severe Angiographic Complications
Time Frame: Baseline procedure, with a mean total procedure time of 52.5 minutes.
Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Baseline procedure, with a mean total procedure time of 52.5 minutes.
12-Month Freedom From Major Adverse Cardiac Events (MACE)
Time Frame: 12 months
The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Jeffrey Chambers, MD, Metropolitan Cardiology Consutants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimated)

March 25, 2010

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORBIT II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Diamondback 360 Orbital Atherectomy System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe