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Coronary Artery DiseaseNCT01887704

Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

A study testing Rotablator, conventional angioplasty and stenting in people with Coronary Artery Disease, run by Capital Medical University at 1 site in China.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Rotablator, conventional angioplasty and stenting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
Jan 2010to May 2013
Phase
Interventional
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xinguo Wang

    Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: Effect of Rotational Atherectomy on Balloon-resistant Calcified Coronary Lesion the During a Long-term Follow-up Study

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.

Read the detailed description

The inclusion criteria included patients presenting drug-resistant angina pectoris who underwent balloon resistant angioplasty.

The exclusion criteria included:

  1. Acute myocardial infarction within the 28 days;
  2. Intolerance to aspirin, clopidogrel, contrast media, or statins;
  3. Angiographic visible thrombus, or dissection;
  4. Left ventricular ejection fraction (LVEF)<35%;
  5. Any type of cancer
  6. Hemorrhagic stroke
Being tested
Rotablator, conventional angioplasty, stenting, Cutting balloon, Aspirin
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.

  • RotablatorDevice

    Also called Rotational atherectomy; High-speed rotational atherectomy

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

  • conventional angioplastyProcedure or surgery

    Also called percutaneous transluminal coronary angioplasty

    Conventional angioplasty was used in both arms.

  • stentingProcedure or surgery

    Also called Implantation of coronary stent

    Stenting was implanted in both arms.

  • Cutting balloonDevice

    Also called Flextome Cutting balloon

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

  • AspirinDrug

    Also called Bayaspirin, 100mg, tablet, oral, Germany

    Aspirin will be administrated in participants in both arms.

  • ClopidogrelDrug

    Also called Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral

    Clopidogrel will be administrated to participants in both arms.

  • Paclitaxel-eluting stentDevice

    Also called Taxus

    Paclitaxel-eluting stent will be used in both arms.

  • zotarolimus-eluting stentDevice

    Also called Resolute, Medtronic CardioVascular

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

  • Everolimus-eluting stentDevice

    Also called Xience V

    Everolimus-eluting stent will be used in both arms.

  • Sirolimus-eluting stentDevice

    Also called Firebird, Shanghai, China

    Sirolimus-eluting stent will be used in both arms.

Study groups in NCT01887704
Study groupRoleWhat they receive
RotablatorExperimentalRotablator 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.
Receives: 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
ConventionalActive comparatorConventional 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.
Receives: 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

What is being measured

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

  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.

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

Secondary outcomes (1)

  1. In hospital endpoints including death, periprocedural MI

    Baseline characteristics were measured on the day of admission to the hospital(baseline).An electrocardiogram was performed 2 h after the procedure. electrocardiograms were required to document any suspicious cardiac ischemic episodes. If any cardiac biomarker elevation was noted after the procedure, further measurements were performed as needed. During their hospital stays, patients were clinically monitored for the occurrence of any adverse events and the need for any additional coronary interventional treatment (In hospital endpoints including death, periprocedural MI).

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

Timeline

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

  1. First posted27 Jun 2013 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2013
  4. Study completionMay 2013

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01887704
Sponsor's protocol ID
ERBRCAL
Status last verified
Jun 2013
First submitted
19 Jun 2013
Last updated
27 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23351416

  • 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.

    PubMed 18550555

Questions about this trial

What is this clinical trial studying?

A study testing Rotablator, conventional angioplasty and stenting in people with Coronary Artery Disease, run by Capital Medical University at 1 site in China.

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 2 inclusion and 6 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 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting (time frame: Participants will be followed for 2 years after the procedure, an expected average of 24 months.). 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 NCT01887704, which also lists 2 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 27 Jun 2013.

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