IN.PACT Global Clinical Study - Full Text View

Purpose

The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

Condition	Intervention	Phase
Peripheral Arterial Disease	Device: IN.PACT Admiral™ Drug Eluting Balloon	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:

Primary Endpoint Clinical Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure.
Primary Endpoint Imaging Cohort [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Primary Patency within 12 months post-index procedure.
Primary Safety Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.

Secondary Outcome Measures:

Major Adverse events [ Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]
- MAE (Major Adverse Events)is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
Target lesion restenosis [ Time Frame: 30 days. 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
Imaging Cohort:

-Duplex-defined binary restenosis of the target lesion at 12 months, or at the time of re-intervention.

Other Outcome Measures:

150mm cohort [ Time Frame: All primary and co-secondary study endpoints as described above will be assessed for this group of subjects separately. ] [ Designated as safety issue: No ]


Estimated Enrollment:	1538
Study Start Date:	May 2012
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: INPACT Admiral DEB The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne) marked medical device utilized within its intended use in the IN.PACT Global trial.	Device: IN.PACT Admiral™ Drug Eluting Balloon IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.

Detailed Description:

Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia(CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.

The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

General inclusion Criteria:

Age ≥ 18 years or minimum age as required by local regulations.
Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.

General exclusion Criteria:

High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609296

Show 68 Study Locations

Sponsors and Collaborators

Medtronic Endovascular

Investigators


Principal Investigator:	Gunnar Tepe, MD	Klinikum Rosenheim
Principal Investigator:	Gary Ansel, MD	MidOhio Cardiology and Vascular Consultants
Principal Investigator:	Marc Bosiers, MD	AZ Sint Blasius
Principal Investigator:	Do-Dai Do, MD	Swiss Cardiovascular Center, Inselspital
Principal Investigator:	Peter Gaines, MD	Sheffield Vascular Institute
Principal Investigator:	Alvaro Razuk, MD	Faculdade de Ciências Médicas da Santa Casa de Sao Paulo

More Information

No publications provided


Responsible Party:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT01609296 History of Changes
Other Study ID Numbers:	10048613
Study First Received:	May 24, 2012
Last Updated:	January 21, 2015
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Ethikkommission Belgium: Ethics Committee Canada: Health Canada Canada: Ministère santé et services sociaux du Québec Colombia: Ethics Committee Czech Republic: Ethics Committee Egypt: Institutional Review Board Finland: Ethics Committee Germany: Ethics Commission Greece: Ethics Committee Hungary: Institutional Ethics Committee Israel: Ethics Commission Italy: Ethics Committee Korea: Institutional Review Board Lithuania: Bioethics Committee Netherlands: Medical Ethics Review Committee (METC) Poland: Ethics Committee Portugal: Ethics Committee for Clinical Research Russia: Ethics Committee Singapore: Ministry of Health Slovakia: Central Ethics Committee - Rozhodnutie Cenralnej etickej komisie Slovenia: Ethics Committee Sweden: Institutional Review Board Switzerland: Ethikkommission United Kingdom: Research Ethics Committee Argentina: Human Research Bioethics Committee

Keywords provided by Medtronic Endovascular:


Peripheral Arterial Disease Drug coated balloon Superficial Femoral Artery Popliteal Femoral Artery Atherosclerosis

Additional relevant MeSH terms:


Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases Arteriosclerosis	Atherosclerosis Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015