Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

NCT01887704 | Completed DMC

• 1 other identifier: ERBRCAL
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective, randomized controlled trial was perform to explore the immediate effect and long-term outcome of rotational atherectomy in patients with balloon resistant coronary lesion.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting

  Follow-up study was performed by experienced doctors through telephone interviews or clinic visits at 1, 3, 6, and 12 months after the procedure, and at every 6 months thereafter. The average duration of follow up was anticipated to be 24 months.

  Participants will be followed for 2 years after the procedure, an expected average of 24 months.

Secondary Outcomes (1)

• In hospital endpoints including death, periprocedural MI

  In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks.

Other Outcomes (1)

• Procedural complications

  Participants will be followed during the process of the procedure, an expected average of 4 hours.

Study Arms (2)

Rotablator

EXPERIMENTAL

Rotablator plus conventional angioplasty and/or stenting was performed in 120 patients in the R group. Rotablator using 140, -160, 000 rpm, small rota burr (burr-to-artery ratio, 0.6:1), avoid drop of \>5000 rpm for 5s. Conventional intervention will be performed in the rotablator group. All subjects were given 100 mg/day aspirin and clopidogrel (300 mg loading dose and 75 mg/day maintenance dosage) at least 24 h before the procedure. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups.

Device: Rotablator; Procedure: conventional angioplasty; Procedure: stenting; Device: Cutting balloon; Drug: Aspirin; Drug: Clopidogrel; Device: Paclitaxel-eluting stent; Device: zotarolimus-eluting stent; Device: Everolimus-eluting stent; Device: Sirolimus-eluting stent

Conventional

ACTIVE COMPARATOR

Conventional angioplasty and/or stenting was performed in 120 patients in the C group. Conventional intervention without rotablator was performed in the C group. All subjects were given 100 mg/day aspirin and clopidogrel (300 mg loading dose and 75 mg/day maintenance dosage) at least 24 h before the procedure. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups.

Procedure: conventional angioplasty; Procedure: stenting; Device: Cutting balloon; Drug: Aspirin; Drug: Clopidogrel; Device: Paclitaxel-eluting stent; Device: zotarolimus-eluting stent; Device: Everolimus-eluting stent; Device: Sirolimus-eluting stent

Interventions

Rotablator DEVICE

Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.

Also known as: Rotational atherectomy; High-speed rotational atherectomy

Rotablator

conventional angioplasty PROCEDURE

Conventional angioplasty was used in both arms.

Also known as: percutaneous transluminal coronary angioplasty

Conventional; Rotablator

stenting PROCEDURE

Stenting was implanted in both arms.

Also known as: Implantation of coronary stent

Conventional; Rotablator

Cutting balloon DEVICE

Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.

Also known as: Flextome Cutting balloon

Conventional; Rotablator

Aspirin DRUG

Aspirin will be administrated in participants in both arms.

Also known as: Bayaspirin, 100mg, tablet, oral, Germany

Conventional; Rotablator

Clopidogrel DRUG

Clopidogrel will be administrated to participants in both arms.

Also known as: Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral

Conventional; Rotablator

Paclitaxel-eluting stent DEVICE

Paclitaxel-eluting stent will be used in both arms.

Also known as: Taxus

Conventional; Rotablator

zotarolimus-eluting stent DEVICE

Zotarolimus-eluting stent will be implanted in participants in both arms.

Also known as: Resolute, Medtronic CardioVascular

Conventional; Rotablator

Everolimus-eluting stent DEVICE

Everolimus-eluting stent will be used in both arms.

Also known as: Xience V

Conventional; Rotablator

Sirolimus-eluting stent DEVICE

Sirolimus-eluting stent will be used in both arms.

Also known as: Firebird, Shanghai, China

Conventional; Rotablator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Drug-resistant angina pectoris
• Balloon resistant and angiographic calcified coronary lesion

You may not qualify if:

• Acute myocardial infarction within 28 days;
• Intolerance to aspirin, clopidogrel, contrast media, or statins;
• Angiographic visible thrombus, dissection;
• LVEF \<35%;
• Any type of cancer;
• Hemorrhagic stroke

Sponsors & Collaborators

• Capital Medical University: lead
• Beijing Anzhen Hospital: collaborator

Study Sites (1)

Xinguo Wang

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (2)

• Chiang MH, Lee WL, Tsao CR, Chang WC, Su CS, Liu TJ, Liang KW, Ting CT. The use and clinical outcomes of rotablation in challenging cases in the drug-eluting stent era. J Chin Med Assoc. 2013 Feb;76(2):71-7. doi: 10.1016/j.jcma.2012.10.004. Epub 2012 Dec 29.

  PMID: 23351416 BACKGROUND

• Roy P, Steinberg DH, Sushinsky SJ, Okabe T, Pinto Slottow TL, Kaneshige K, Xue Z, Satler LF, Kent KM, Suddath WO, Pichard AD, Weissman NJ, Lindsay J, Waksman R. The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents. Eur Heart J. 2008 Aug;29(15):1851-7. doi: 10.1093/eurheartj/ehn249. Epub 2008 Jun 11.

  PMID: 18550555 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atherectomy, Coronary; Angioplasty, Balloon, Coronary; Stents; Aspirin; Tablets; Clopidogrel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques; Angioplasty, Balloon; Prostheses and Implants; Equipment and Supplies; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yujie Zhou, MD.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 27, 2013
• Study Start: January 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

CN (1)