Clinical trial NCT01092416: Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CAD
Severely calcified lesion
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
timeFrame: 30 days
measure: Primary Efficacy Endpoint: Procedural Success
timeFrame: Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.
Secondary outcomes:
measure: Angiographic Success
timeFrame: Baseline procedure, with a mean total procedure time of 52.5 minutes.
measure: Severe Angiographic Complications
timeFrame: Baseline procedure, with a mean total procedure time of 52.5 minutes.
measure: 12-Month Freedom From Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Trinity Hospital
state: Alabama
city: Montgomery
country: United States
facility: Baptist Montgomery South
state: Alabama
city: Gilbert
country: United States
facility: Mercy Gilbert
state: Arizona
city: Beverly Hills
country: United States
facility: Cedar Sinai Los Angeles
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Palm Springs
country: United States
facility: Eisenhower Medical Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Cardiology Center
state: California
city: Sacramento
country: United States
facility: Sutter Memorial Hospital
state: California
city: Daytona Beach
country: United States
facility: Florida Hospital Memorial
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Orlando Regional
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Gardens
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana Heart Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Saint Vincents Indianapolis
state: Indiana
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Ashland
country: United States
facility: King's Daughters / Kentucky Heart Foundation
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Detroit
country: United States
facility: St. John's Hospital
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart & Vascular
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Newark
country: United States
facility: Saint Michaels
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill
state: New York
city: Roslyn
country: United States
facility: St. Francis
state: New York
city: Dayton
country: United States
facility: Good Samaritan Dayton
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Beaver
country: United States
facility: The Heart and Vascular Center
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr / Lankenau
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary's
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital-DeSoto
state: Tennessee
city: Dallas
country: United States
facility: Baylor
state: Texas
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
city: Houston
country: United States
facility: St. Luke's
state: Texas
city: Layton
country: United States
facility: Davis Hospital
state: Utah
city: Bellingham
country: United States
facility: Saint Joe Bellingham / North Cascade Cardiology
state: Washington
Study officials:
affiliation: Metropolitan Cardiology Consutants
name: Jeffrey Chambers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.