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AtherosclerosisNCT02118532

The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population

A study testing IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter in people with Atherosclerosis, run by Medtronic Endovascular at 15 sites 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 purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for the interventional treatment of new and non-stented restenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Atherosclerosis
What is being tested?
IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
15 sitesChina
Study dates
Mar 2014to Sep 2016
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years and ≤ 85 years.
  • Subject with documented diagnosis of peripheral arterial disease (PAD) classified as Rutherford class 2-3-4 in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) above the knee, located in the arterial segment starting at least 1 cm beyond the Common femoral artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella (distal anatomical landmark).
  • Target lesion consists of a single de novo or non-stented restenotic lesion (or a tandem lesion) or is a combination lesion
  • Reference vessel diameter ≥ 4 mm and ≤ 7 mm by visual estimate.
  • Subject able to walk without assistive devices (e.g. walker, cane).
  • If subject has ipsilateral/contralateral iliac disease that requires treatment during the index procedure
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  • Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as < 50% diameter stenosis).
  • Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before index procedure and willing to use a reliable method of birth control for the duration of the study or must have documented adequate birth control.
  • Signed and dated Patient Informed Consent (PIC) form.
  • Understands and accepts the duration of the study and is able and willing to comply with all requirements, including follow-up visits and evaluations.
  • Life expectancy, in the Investigator's opinion, of at least 12 months.

Who cannot join

  • In the investigator's opinion subject is unlikely to comply with the followup schedule.
  • Stroke or STEMI within the 3 months prior to index procedure.
  • Either local or systemic thrombolytic therapy within 48 hours prior to the index procedure.
  • Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT).
  • Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
  • Breastfeeding woman.
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  • Chronic renal insufficiency with serum creatinine > 2.5 mg/dL within 14 days prior to index procedure.
  • WBC < 3.0 (3,000 cells/mm3) within 14 days prior to index procedure.
  • PLT count < 80,000 cells/mm3 or > 700,000 cells/mm3 within 14 days prior to index procedure.
  • Known or suspected active systemic infection evidenced by WBC > 14.0 (14000/mm3) within 14 days prior to index procedure.
  • Diagnosed with bleeding diatheses or hypercoagulable state.
  • Subject is enrolled in another investigational device, drug or biologic study or subject was previously enrolled to the IN.PACT SFA China trial.
  • Any major (e.g., cardiac. peripheral, abdominal) surgical procedure or intervention performed within 30 days prior to the index procedure.
  • Any major (e.g., cardiac. peripheral, abdominal) elective procedure or intervention within 30 days post index procedure.
  • Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure.
  • Presence of additional lesions in the target vessel that require treatment during index procedure but do not meet the definitions of tandem lesions.
  • Target lesion is an in-stent or post-DEB restenosis or has been previously treated with bypass surgery.
  • Failure to successfully cross the target lesion with a guide wire
  • Lesion within or adjacent to an aneurysm.
  • Acute or sub-acute thrombus in the target vessel.
  • Angiographic evidence of severe calcification
  • Target lesion known in advance of enrollment to require treatment with alternative therapy such as drug-eluting stent (DES), drug-eluting balloon (DEB), laser, atherectomy, cryoplasty, re-entry devices, cutting/scoring balloon, brachytherapy. Use of embolic protection devices is also prohibited.
  • Pre-dilation resulted in a major ( ≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis > 70% and translesional peak gradient > 10mm Hg.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • 301 Hospital/Chinese PLA General Hospital

    Beijing

  • Anzhen Hospital, Capital Medical University

    Beijing

  • Peking University First Hospital

    Beijing

  • Xuanwu Hospital, Capital Medical University

    Beijing

  • West China Hospital

    Chengdu, 610041

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

  • The First Affiliated Hospital, Dalian Medical University

    Dalian

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • The 1stAffiliated Hospital of Sun Yat-sen University

    Guangzhou

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin

  • The first affiliated Hospital of Harbin Medical University

    Harbin

  • Nanjing Drum Tower Hospital

    Nanjing

  • Shanghai 9th People Hospital Affiliated Shanghai Jiao Tong University School of Medecine

    Shanghai, 200011

  • Zhongshan Hospital, Fudan University

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

Other trials in China

About this study

The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for the interventional treatment of new and non-stented restenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.

Conditions
Atherosclerosis
Being tested
IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Keywords
Atherosclerosis, Superficial Femoral Artery, Proximal Popliteal Artery
Medical subject headings
Atherosclerosis

What participants receive

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

  • IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon CatheterDevice

    IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter originally developed, approved and commercialized by Invatec Technology Center GmbH is the investigational medical device used in the study. Medtronic Inc. acquired Invatec on April 21, 2010. Medtronic

Study groups in NCT02118532
Study groupRoleWhat they receive
IN.PACT AdmiralExperimentalNot described
Receives: Device: IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

What is being measured

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

  1. Primary effectiveness endpoint: Primary patency within 12 months post-index procedure

    Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR)1 and freedom from restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4

    Measured: 12 months

  2. Primary Safety Endpoint

    A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and freedom from clinicallydriven TLR within 30-day post-index procedure

    Measured: 30 days post-index procedure

Secondary outcomes (18)

  1. Major Adverse Events

    MAE is defined as all-cause mortality, clinically-driven Target Vessel Revascularization (TVR), major target limb amputation or thrombosis at the target lesion site, through 12 months

    Measured: 12 months

  2. Death of any cause

    Death of any cause at 30 days, 6 and 12 months

    Measured: 30 days, 6 and 12 months

  3. Target Lesion Revascularization

    Clinically-driven TLR at 30 days, 6 and 12 months TLR at 6 and 12 months

    Measured: 30 days, 6 and 12 months

  4. Target Vessel Revascularization

    Clinically-driven TVR at 30 days, 6 and 12 months TVR at 6 and 12 months

    Measured: 30 days, 6 and 12 months

  5. Major target limb amputation

    Major target limb amputation at 30 days, 6 and 12 months

    Measured: 30 days, 6 and 12 months

  6. Thrombosis at the target lesion site

    Thrombosis at the target lesion site at 30 days, 6 and 12 months

    Measured: 30 days, 6 and 12 months

  7. Time to first clinically-driven Target Lesion Revascularization

    Time to first clinically-driven TLR through 12 months post-index procedure

    Measured: 12 months

  8. Primary sustained clinical improvement

    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

    Measured: 6 and 12 months

  9. Secondary sustained clinical improvement

    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

    Measured: 6 and 12 months

  10. Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion

    Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point

    Measured: 6 and 12 months

  11. Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion

    Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point

    Measured: 6 and 12 months

  12. Walking capacity assessment

    Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 30 days, 6 and 12 months

    Measured: 30 days, 6 and 12 months

  13. Walking distance

    Walking distance as assessed by 6 Minute Walk Test (6MWT) at 30 days, 6 and 12 months as change from baseline

    Measured: 30 days, 6 and 12 months

  14. Quality of life assessment

    Quality of life assessment by EQ5D questionnaire at 30 days, 6 and 12 months as change from baseline

    Measured: 30 days, 6 and 12 months

  15. Device success

    Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).

    Measured: Post procedure

  16. Procedural success

    Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab assessment.

    Measured: Post procedure

  17. Clinical success

    Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.

    Measured: Post procedure

  18. Days of hospitalization due to the target lesion

    Days of hospitalization due to the target lesion from procedure through 6 and 12 months

    Measured: 6 and 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 posted21 Apr 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionAug 2016
  4. Study completionSep 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
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02118532
Sponsor's protocol ID
IN.PACT SFA China
Status last verified
Dec 2016
First submitted
11 Apr 2014
Last updated
30 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.

    PubMed 31543165

  • Chen Z, Guo W, Jiang W, Wang F, Fu W, Zou Y, Deckers S, Li P, Popma JJ, Jaff MR. IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population. J Endovasc Ther. 2019 Aug;26(4):471-478. doi: 10.1177/1526602819852084. Epub 2019 Jun 17.

    PubMed 31204595

  • Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25.

    PubMed 30690141

Questions about this trial

What is this clinical trial studying?

A study testing IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter in people with Atherosclerosis, run by Medtronic Endovascular at 15 sites 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 11 inclusion and 23 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 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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?

Primary effectiveness endpoint: Primary patency within 12 months post-index procedure (time frame: 12 months). 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 NCT02118532, which also lists 3 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 30 Dec 2016.

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