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Part I Mechanisms of Restenosis and Alternative Treatments 3

1.Restenosis Following Angioplasty: Scope of the Problem[Spencer B. King, III, MD] 3

Foreword:Martin B. Leon, MD 5

Preface 7

Preface(Adopted and Modified from the first edition) 9

Contributors 11

2.Restenosis and Remodeling[Robert S. Schwartz, MD and David R. Holmes, Jr., MD] 13

3.Adventitial Remodeling Associated with Postangioplasty Restenosis[Josiah N. Wilcox. PhD nad Neal A. Scott, MD. PhD] 21

24.Local Delivery of Radionuclides to Prevent Restenosis[Ron Waksman, MD, FACC, Rosanna C. Chan. PhD. Lisa R. Karam, PhD, and Brian E. Zinmmerman, PhD] 27

4.Animal Models to Study Restenosis[Keith A. Robinson,PhD］ 31

5.Artetial Remodeling as a Mechanism of Restenosis Following Intetventional Coronary Procedures: Evidence from Serial Intravascualr Ultrasound Studies[Gary S. Mintz, MD, Jeffrey J. Popma, MD, Augusto D. Pichard. MD, Kenneth M. Kent,MD, Lowe 43

6. Antirestenosis Alternatives for the Next Millennium[Michael J.B. Kutryk MD. PhD.FRCPC and Patrick W. Serruys MD,PhD, FACC, FESC] 53

Part II Radiation Biology and Vascular Pathology 63

7.The Basic Radiobiology of Intravasular Irradiation [Eric J. Hall, D Phil, DSc, FACR,Richard C. Miller. PhD. and David J. Brenner. PhD. DSc] 63

8. Radiation Injury to Blood Vessels[Luis F. Fajardo, L.G. MD] 73

9. Radiation Biology Concepts for the Use of Radiation to Prevent Restenosis[James B. Mitchell. PhD] 83

10.Radiation Inhibition versus Induction of Vascular Restenosis: The Role of the Monocyte-Derived Macrophage Philoip Rubin. MD, Jacqueline P. Williams. PhD, Jacob Finkelstein, PhD,Richard Pomerantz,MD,and Paul Okunieff, MD] 103

11.Mechanisms by Which Radiation May Prevent Restenosis:Inhibition of Cell Proliferation and Vascular Remodeling[Josiah N. Wilcox, PhD, Spencer B. King. MD,and Ron Wsksman, MD, FACC] 127

12.Potential Roles for Nitric Oxide and Transforming Growth Factor-β1 in Endovascualr Brachytherapy[Yoram Vodovotz, PhD and Ron Wahsman, MD. FACC] 139

Part III Radiation Physics and Dosimetry for Vascular Brachytherapy 149

13.Dosimetry of Sealed Beat Particle Sources[Chiristopher G. Soares.PhD] 149

14. Basic Physics of Gamma Isotopes[Shirish K. Jani, PhD] 167

15. Intravascular Brachytherapy Physics: Review of Radiation Sources and Techniques[Howard I. Amols. PhD] 177

16.Intravascular Brachytherapy: A Health Physics Perspective[Stephen Balter, PhD] 191

Part IV Radiation for Restenosis in Animal Models 207

17.External Beam Irradiation, Stent Injury, and Neointimal Hyperplasia: Results in a Porcine Model[Robert S. Schwartz, MD, FACC. Thomas M. Koral PhD. Jean Gregoire, MD, Myung Ho Jeong. MD. PhD. William D. Edwards, MD, FACC, Allan R, Camrud, 207

18. Comparison of Endovascular and External Beam Lrradiation in the Prevention of Restenosis[Monique M.H. Marijianowski, PhD, Keith Robinson, PhD, and Ian R. Crocker, MD] 221

19.External Beam Ionizing Irradiation for the Prevention of Restenosis Past and Future[Morris Mosseri, MD and Zeev Weshier, MD] 231

20.Intracoronary Ganma Irradiation Studies in the Swine Model of Restenlsis[Ron Waksman, MD, FACC] 245

21.Intra-Atrerial Beta Irradiation and the Prevention of Neointimal Hyperplasia in a Hypercholesterolemic Rabbit Restenosis Model[Vitali Verin, MD, Youri Popowski, MD, Philip Urban, MD, Jean Belenger, Mirelippe Redard, Manuel Costa, Marie-C 257

22.Endovascular Beta Radiation in the Swine Model[Ron Waksman, MD, FACC] 273

23.Endovascular Radiation with Beta and Gamma Sources in the Porcine Model[Albert E. Raizner, MD, Wojciech Mazur, MD, and M, Nadir Ali, MD] 287

25.Intravasular Red Light Therapy: Long-Term Results from the Human Clinical Trial[Nicholas N. Kipshidze, MD, PHD, Ican DeScheerder, MD, PhD, Upendra Kaul, MD, Harry Sahota, MD and Michael H, Keelan Jr., MD] 303

Part V Stents and Radiation 313

26.Dosimetric Considerations and Dose Measurement Analysis of Phosphorus 32 Beta-Emitting Stents: A Review[Charles W, Coffey, II, PhD, Dennis M. Duggan, PhD, and Robin C. Reddick, PhD] 313

27.Radioactive Stents; The European Experience[Christoph Hehrlein, MD] 333

28.Long-Term Effects of Phosphorus 32 Radioactive Stents in Experimental Models[Andrw J, Carter, DO, FACC] 343

29.Pathology of Radioactive Stents[Renu Virmani, MD, Andrew J, Carter. Do, Russ M, Jones, and Andrew Farb, MD] 353

30.Catheter-Based Radiation Therapy in Stented Arteries[Ron Waksntan, MD, FACC] 365

Part VI Vascular Radiation and Peripheral Vascular Disease 375

31.Peripheral Vafscular Radiation Therapy: Problems Related to Technical Ap-plications[Louis G. Marlin, MD] 375

32.Restenosis in Peripheral Vascular Disesae[Alan B. Lumsden, M. Julia MacDonald, and Changyi Chen] 387

33.Intravascular Irradiation Therapy[Dieter D. Liermann, R, Bauernsachs, Bernard Schopohl, and H.D. Bottcher] 395

34.Peripheral Vascular Brachytherapy[Ron Waksman, MD, FACC] 407

35.External Radiation Therapy for Patients with Arteriovcenous Dialysis Shunts[Suhrid Parikh, MBBS, MS, MCH and Dattatreyudu Nori, MD, FACR] 417

Part VII Endovascular Radiation Clinical Trials in Coronary Arteries 435

36.Intracoronary Radiation Therapy for Restenosis: The Clinical Trials[Ron Waksman, MD, FACC] 435

37. Intracoronary Gamma Radiation Following Balloon Angioplasty: The Venezuelan Experience[Jose A. Condado, MD, Ron Waksman, MD, FACC, Orlando Guraiel, MD, Harry Acquatella, MD, Carlos Calderas, MD, Ian R. Crocker, MD, and Samuel F. Liprie, 449

38.Intracoronary Gamma Radiation and Stents for Restenotic Lesins: The Scripps Clinic Experience[Paul S, Teirstein, MD, Vincent Massullo, MD, Shirish Jani, PhD, and Prabhakar Tripuraneni, MD] 463

39.Clinical Restenosis Trials Using Beta Energy Radiation[Spencer B. King III, MD and Raoul Bonan, MD] 469

40.Lessons from the Feasibility Radiactive(IRIS) Stent Trials[Tim A. Fischell, MD, Andrew Carter, DO, Malcolm Foster, MD, Robert E. Fischell, ScD, and David R. Fischell, PhD] 475

Part VIII Systems for Endovascular Radiation Therapy 485

41.Best: Manually Loaded Iridium 192 Ribbon[Shirish K. Jani, PhD, Gerard B. Huppe, MS, Vincent Massullo, Md, Prabhakar Tripuraneni, MD, and Paul Teirstein, MD] 485

42.NovosteTM Beta-CathTM Intracoronary Beta Radiation System[Richard A. Hillstead] 489

43.Nucletron Afterloading Technology for Brachytherapy: The Peripheral System[Edgar G. Loffter, PhD and Frits M. van Krieken, MSc, PhD] 499

44.The Guidant Coronary Source Wire System[Albert Raizner, MD, Richard V, Calfee, PhD, M. Nadir Ali, MD, Anthony J, Bradshaw, BS, ID, and Robert P, Eno, MBA] 505

45.Use of Liquid-Filled Balloons for Coronary Irradiation[Judah Weinberger, MD, PhD and F.F.(Russ) Knapp, Jr., PhD] 521

46.Clinical Trials Using Beta Energy Radiation: Experimental and Clinical Experience with Schneider-Sauerwein Intravascular Radiation System[Vitali Verin, MD and Youri Popowski, MD] 537

47.The AnigioradTM Gamma Wire System[David P. Faxon, MD and Samuel F. Liprie, PD (Nuc)] 553

48.Intravascular Soft X-Ray Therapy[Victor Chornenky, PhD] 561

Part IX Regulatory and Health Care Milieu Issues 581

50.Radiation Safety Requirements for Vascular Radiotherapy in the Catheteri-zation Laboratory[Billy G. Bass, PhD] 581

51.Regulatory Considerations for Approval of Vascular Radiation Studies in the United States[Tara A. Ryan, MS, MBA] 593

52.The Economics of Restenosis: Implications for Brachytherapy[William S Weintraub, MD] 601

Index 613