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

NCT01092416 | Completed Results DMC

• 1 other identifier: ORBIT II
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 51

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

CAD; Severely calcified lesion

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days

• 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.

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

Secondary Outcomes (3)

• Angiographic Success

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

• Severe Angiographic Complications

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

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

  12 months

Interventions

Diamondback 360 Orbital Atherectomy System DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (51)

Trinity Hospital

Birmingham, Alabama, 35213, United States

Location

Baptist Montgomery South

Montgomery, Alabama, 36116, United States

Location

Mercy Gilbert

Gilbert, Arizona, 85297, United States

Location

Cedar Sinai Los Angeles

Beverly Hills, California, 90210, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

Eisenhower Medical Center

Palm Springs, California, 92270, United States

Location

Desert Cardiology Center

Rancho Mirage, California, 92270, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95825, United States

Location

Florida Hospital Memorial

Daytona Beach, Florida, 32117, United States

Location

North Florida Regional

Gainesville, Florida, 32614, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Orlando Regional

Orlando, Florida, 32806, United States

Location

Palm Beach Gardens

Palm Beach Gardens, Florida, 33410, United States

Location

Winter Haven

Winter Haven, Florida, 33881, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana Heart Hospital

Indianapolis, Indiana, 46250, United States

Location

Saint Vincents Indianapolis

Indianapolis, Indiana, 46290, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Iowa Heart

Des Moines, Iowa, 50314, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

King's Daughters / Kentucky Heart Foundation

Ashland, Kentucky, 41101, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Cape Cod Research Institute

Hyannis, Massachusetts, 02601, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201-2018, United States

Location

St. John's Hospital

Detroit, Michigan, 48236, United States

Location

St. Joseph Mercy

Pontiac, Michigan, 48341, United States

Location

Lakeland

Saint Joseph, Michigan, 49085, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 55407, United States

Location

United Heart & Vascular

Saint Paul, Minnesota, 55102, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Saint Michaels

Newark, New Jersey, 07102, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New York Methodist Hospital

Brooklyn, New York, 71878, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Lenox Hill

New York, New York, 10075, United States

Location

St. Francis

Roslyn, New York, 11576, United States

Location

Good Samaritan Dayton

Dayton, Ohio, 45405, United States

Location

Oklahoma Heart

Oklahoma City, Oklahoma, 73120, United States

Location

The Heart and Vascular Center

Beaver, Pennsylvania, 15009, United States

Location

Bryn Mawr / Lankenau

Bryn Mawr, Pennsylvania, 19010, United States

Location

St. Mary's

Langhorne, Pennsylvania, 19047, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Baptist Memorial Hospital-DeSoto

Memphis, Tennessee, 38120, United States

Location

Baylor

Dallas, Texas, 75226, United States

Location

Memorial Hermann

Houston, Texas, 77030, United States

Location

St. Luke's

Houston, Texas, 77030, United States

Location

Davis Hospital

Layton, Utah, 84041, United States

Location

Saint Joe Bellingham / North Cascade Cardiology

Bellingham, Washington, 98225, United States

Location

Related Publications (15)

• 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.

  PMID: 25910525 RESULT

• 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.

  PMID: 24852804 RESULT

• 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.

  PMID: 28162989 RESULT

• 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.

  PMID: 27084293 RESULT

• 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.

  PMID: 30982659 RESULT

• 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.

  PMID: 30243964 RESULT

• 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.

  PMID: 29454531 RESULT

• 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.

  PMID: 29452841 RESULT

• 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.

  PMID: 29117920 RESULT

• 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.

  PMID: 28786143 RESULT

• 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.

  PMID: 28733974 RESULT

• 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.

  PMID: 28191873 RESULT

• 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.

  PMID: 27567020 RESULT

• 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.

  PMID: 26984932 RESULT

• 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.

  PMID: 26331279 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Cardiovascular Systems, Inc.

clinicaltrials_csi@csi360.com

6512591600

Study Officials

• Jeffrey Chambers, MD

  Metropolitan Cardiology Consutants

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2016
• Last Updated: July 18, 2023
• Results First Posted: January 6, 2016

Record last verified: 2023-07

Locations

US (51)