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Coronary Artery DiseaseORBIT IINCT01092416

Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions

A study testing Diamondback 360 Orbital Atherectomy System in people with Coronary Artery Disease, run by Abbott Medical Devices at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Diamondback 360 Orbital Atherectomy System
Type of treatment
Medical device
How many people
443 participants
Where
51 sitesUnited States
Study dates
May 2010to Jan 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 33Show fewer
  • 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.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • King's Daughters / Kentucky Heart Foundation

    Ashland, Kentucky, 41101

  • Emory University

    Atlanta, Georgia, 30322

  • The Heart and Vascular Center

    Beaver, Pennsylvania, 15009

  • Saint Joe Bellingham / North Cascade Cardiology

    Bellingham, Washington, 98225

  • Cedar Sinai Los Angeles

    Beverly Hills, California, 90210

  • Trinity Hospital

    Birmingham, Alabama, 35213

  • New York Methodist Hospital

    Brooklyn, New York, 71878

  • Bryn Mawr / Lankenau

    Bryn Mawr, Pennsylvania, 19010

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Baylor

    Dallas, Texas, 75226

  • Good Samaritan Dayton

    Dayton, Ohio, 45405

  • Florida Hospital Memorial

    Daytona Beach, Florida, 32117

  • Iowa Heart

    Des Moines, Iowa, 50314

  • Detroit Medical Center

    Detroit, Michigan, 48201-2018

  • St. John's Hospital

    Detroit, Michigan, 48236

  • North Florida Regional

    Gainesville, Florida, 32614

  • Mercy Gilbert

    Gilbert, Arizona, 85297

  • Memorial Hermann

    Houston, Texas, 77030

  • St. Luke's

    Houston, Texas, 77030

  • Cape Cod Research Institute

    Hyannis, Massachusetts, 02601

  • Indiana Heart Hospital

    Indianapolis, Indiana, 46250

  • Saint Vincents Indianapolis

    Indianapolis, Indiana, 46290

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • St. Mary's

    Langhorne, Pennsylvania, 19047

  • Davis Hospital

    Layton, Utah, 84041

  • Good Samaritan Hospital

    Los Angeles, California, 90017

  • Baptist Memorial Hospital-DeSoto

    Memphis, Tennessee, 38120

  • Abbott Northwestern

    Minneapolis, Minnesota, 55407

  • Baptist Montgomery South

    Montgomery, Alabama, 36116

  • Community Hospital

    Munster, Indiana, 46321

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Lenox Hill

    New York, New York, 10075

  • Saint Michaels

    Newark, New Jersey, 07102

  • Munroe Regional Medical Center

    Ocala, Florida, 34471

  • Oklahoma Heart

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Orlando Regional

    Orlando, Florida, 32806

  • Palm Beach Gardens

    Palm Beach Gardens, Florida, 33410

  • Eisenhower Medical Center

    Palm Springs, California, 92270

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • St. Joseph Mercy

    Pontiac, Michigan, 48341

  • Maine Medical Center

    Portland, Maine, 04102

  • Desert Cardiology Center

    Rancho Mirage, California, 92270

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • St. Francis

    Roslyn, New York, 11576

  • Sutter Memorial Hospital

    Sacramento, California, 95825

  • Lakeland

    Saint Joseph, Michigan, 49085

  • United Heart & Vascular

    Saint Paul, Minnesota, 55102

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Winter Haven

    Winter Haven, Florida, 33881

Other trials in United States

About this study

Official title: 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.

Being tested
Diamondback 360 Orbital Atherectomy System
Keywords
CAD, Severely calcified lesion
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diamondback 360 Orbital Atherectomy SystemDevice

    Diamondback 360 Orbital Atherectomy System. The (OAS) utilizes a diamond-coated eccentric crown that, while rotating over an atherectomy guide wire, expands the lumen diameter laterally via centrifugal forces (up to a maximum orbit diameter for a given rotational speed and crown diameter). It is a minimally invasive PCI procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)

    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.

    Measured: 30 days

  2. Primary Efficacy Endpoint: Procedural Success

    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.

    Measured: Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.

Secondary outcomes (3)

  1. Angiographic Success

    Angiographic success was defined as success in facilitating stent delivery with <50% residual stenosis and without severe angiographic complications.

    Measured: Baseline procedure, with a mean total procedure time of 52.5 minutes.

  2. Severe Angiographic Complications

    Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.

    Measured: Baseline procedure, with a mean total procedure time of 52.5 minutes.

  3. 12-Month Freedom From Major Adverse Cardiac Events (MACE)

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJan 2013
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01092416
Sponsor's protocol ID
ORBIT II
Acronym
ORBIT II
Status last verified
Jul 2023
First submitted
23 Mar 2010
Last updated
18 Jul 2023
Data monitoring committee
Yes

Publications

  • Genereux P, Lee AC, Kim CY, Lee M, Shlofmitz R, Moses JW, Stone GW, Chambers JW. Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial). Am J Cardiol. 2015 Jun 15;115(12):1685-90. doi: 10.1016/j.amjcard.2015.03.009. Epub 2015 Mar 24.

    PubMed 25910525

  • Chambers JW, Feldman RL, Himmelstein SI, Bhatheja R, Villa AE, Strickman NE, Shlofmitz RA, Dulas DD, Arab D, Khanna PK, Lee AC, Ghali MG, Shah RR, Davis TP, Kim CY, Tai Z, Patel KC, Puma JA, Makam P, Bertolet BD, Nseir GY. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014 May;7(5):510-8. doi: 10.1016/j.jcin.2014.01.158.

    PubMed 24852804

  • Lee M, Genereux P, Shlofmitz R, Phillipson D, Anose BM, Martinsen BJ, Himmelstein SI, Chambers JW. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017 Jun;18(4):261-264. doi: 10.1016/j.carrev.2017.01.011. Epub 2017 Jan 23.

    PubMed 28162989

  • Genereux P, Bettinger N, Redfors B, Lee AC, Kim CY, Lee MS, Shlofmitz RA, Moses JW, Stone GW, Chambers JW. Two-year outcomes after treatment of severely calcified coronary lesions with the orbital atherectomy system and the impact of stent types: Insight from the ORBIT II trial. Catheter Cardiovasc Interv. 2016 Sep;88(3):369-77. doi: 10.1002/ccd.26554. Epub 2016 Apr 16.

    PubMed 27084293

  • Shlofmitz E, Martinsen BJ, Behrens AN, Ali ZA, Lee MS, Puma JA, Shlofmitz RA, Chambers JW. Direct Stenting in Patients Treated with Orbital Atherectomy: An ORBIT II Subanalysis. Cardiovasc Revasc Med. 2019 Jun;20(6):454-460. doi: 10.1016/j.carrev.2019.03.011. Epub 2019 Mar 21.

    PubMed 30982659

  • Lee MS, Shlofmitz RA, Shlofmitz E, Behrens AN, Revtyak G, Martinsen BJ, Chambers JW. Procedural and Long-Term Ischemic Outcomes of Tight Subtotal Occlusions Treated with Orbital Atherectomy: An ORBIT II Subanalysis. Cardiovasc Revasc Med. 2019 Jul;20(7):563-568. doi: 10.1016/j.carrev.2018.09.011. Epub 2018 Sep 13.

    PubMed 30243964

  • Lee MS, Shlofmitz RA, Shlofmitz E, Srivastava PK, Kong J, Grines C, Revytak G, Chambers JW. Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis. Cardiovasc Revasc Med. 2018 Apr;19(3 Pt A):268-272. doi: 10.1016/j.carrev.2017.09.017. Epub 2017 Oct 3.

    PubMed 29454531

  • Lee MS, Shlofmitz RA, Martinsen BJ, Sethi S, Chambers JW. Impact of age following treatment of severely calcified coronary lesions with the orbital atherectomy system: 3-year follow-up. Cardiovasc Revasc Med. 2018 Sep;19(6):655-659. doi: 10.1016/j.carrev.2018.01.011. Epub 2018 Jan 31.

    PubMed 29452841

  • Lee MS, Anose BM, Martinsen BJ, Lee AC, Shlofmitz RA, Chambers JW. Orbital atherectomy treatment of severely calcified native coronary lesions in patients with prior coronary artery bypass grafting: Acute and one-year outcomes from the ORBIT II trial. Cardiovasc Revasc Med. 2018 Jul;19(5 Pt A):498-502. doi: 10.1016/j.carrev.2017.10.009. Epub 2017 Nov 5.

    PubMed 29117920

  • Shlofmitz E, Martinsen B, Lee M, Genereux P, Behrens A, Kumar G, Puma J, Shlofmitz R, Chambers J. Utilizing intravascular ultrasound imaging prior to treatment of severely calcified coronary lesions with orbital atherectomy: An ORBIT II sub-analysis. J Interv Cardiol. 2017 Dec;30(6):570-576. doi: 10.1111/joic.12423. Epub 2017 Aug 7.

    PubMed 28786143

  • Lee MS, Martinsen BJ, Lee AC, Behrens AN, Shlofmitz RA, Kim CY, Chambers JW. Impact of diabetes mellitus on procedural and one year clinical outcomes following treatment of severely calcified coronary lesions with the orbital atherectomy system: A subanalysis of the ORBIT II study. Catheter Cardiovasc Interv. 2018 May 1;91(6):1018-1025. doi: 10.1002/ccd.27208. Epub 2017 Jul 22.

    PubMed 28733974

  • Lee MS, Martinsen BJ, Shlofmitz R, Shlofmitz E, Lee AC, Chambers J. Orbital atherectomy treatment of severely calcified coronary lesions in patients with impaired left ventricular ejection fraction: one-year outcomes from the ORBIT II study. EuroIntervention. 2017 Jun 20;13(3):329-337. doi: 10.4244/EIJ-D-16-00301.

    PubMed 28191873

  • Lee MS, Lee AC, Shlofmitz RA, Martinsen BJ, Hargus NJ, Elder MD, Genereux P, Chambers JW. ORBIT II sub-analysis: Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System. Catheter Cardiovasc Interv. 2017 Apr;89(5):841-848. doi: 10.1002/ccd.26778. Epub 2016 Aug 27.

    PubMed 27567020

  • Lee MS, Shlofmitz E, Shlofmitz R, Sahni S, Martinsen B, Chambers J. Outcomes After Orbital Atherectomy of Severely Calcified Left Main Lesions: Analysis of the ORBIT II Study. J Invasive Cardiol. 2016 Sep;28(9):364-9. Epub 2016 Mar 15.

    PubMed 26984932

  • Kim CY, Lee AC, Wiedenbeck TL, Lee MS, Chambers JW. Gender differences in acute and 30-day outcomes after orbital atherectomy treatment of de novo, severely calcified coronary lesions. Catheter Cardiovasc Interv. 2016 Mar;87(4):671-7. doi: 10.1002/ccd.26163. Epub 2015 Sep 2.

    PubMed 26331279

Questions about this trial

What is this clinical trial studying?

A study testing Diamondback 360 Orbital Atherectomy System in people with Coronary Artery Disease, run by Abbott Medical Devices at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01092416, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.

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