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

NCT02118532 | Completed DMC

• 1 other identifier: IN.PACT SFA China
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Atherosclerosis

Keywords

Atherosclerosis; Superficial Femoral Artery; Proximal Popliteal Artery

Outcome Measures

Primary Outcomes (2)

• 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

  12 months

• 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

  30 days post-index procedure

Secondary Outcomes (18)

• Major Adverse Events

  12 months

• Death of any cause

  30 days, 6 and 12 months

• Target Lesion Revascularization

  30 days, 6 and 12 months

• Target Vessel Revascularization

  30 days, 6 and 12 months

• Major target limb amputation

  30 days, 6 and 12 months

Study Arms (1)

IN.PACT Admiral

EXPERIMENTAL

Device: IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Interventions

IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter DEVICE

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

IN.PACT Admiral

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (15)

301 Hospital/Chinese PLA General Hospital

Beijing, China

Location

Anzhen Hospital, Capital Medical University

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

West China Hospital

Chengdu, 610041, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

The First Affiliated Hospital, Dalian Medical University

Dalian, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location

The 1stAffiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, China

Location

The first affiliated Hospital of Harbin Medical University

Harbin, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

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

Shanghai, 200011, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

Shengjing Hospital of China Medical University

Shenyang, China

Location

Related Publications (3)

• 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.

  PMID: 31543165 DERIVED

• 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.

  PMID: 31204595 DERIVED

• 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.

  PMID: 30690141 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhong Chen, Prof

  Vascular Department Anzhen Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

• Wei Guo, Prof

  Vascular Department 301 Hospital

  PRINCIPAL INVESTIGATOR

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: April 11, 2014
• First Posted: April 21, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 30, 2016

Record last verified: 2016-12

Locations

CN (15)